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auto-save: 2026-07-12T23:51:20 (1 files) — backups/
367d88875ebd025489566a5277add6677936d32a · 2026-07-12 23:51:27 -0700 · Steve Abrams
Files touched
A backups/medications-backup-20260712-232800.sql
Diff
commit 367d88875ebd025489566a5277add6677936d32a
Author: Steve Abrams <steve@designerwallcoverings.com>
Date: Sun Jul 12 23:51:27 2026 -0700
auto-save: 2026-07-12T23:51:20 (1 files) — backups/
---
backups/medications-backup-20260712-232800.sql | 378 +++++++++++++++++++++++++
1 file changed, 378 insertions(+)
diff --git a/backups/medications-backup-20260712-232800.sql b/backups/medications-backup-20260712-232800.sql
new file mode 100644
index 0000000..1408f13
--- /dev/null
+++ b/backups/medications-backup-20260712-232800.sql
@@ -0,0 +1,378 @@
+--
+-- PostgreSQL database dump
+--
+
+\restrict w1pJsC1vbAhfLqVFmVD3UEPegeqyZUVzBgSLWVgP2aWouS0AJfSEC5EqsgtpnsF
+
+-- Dumped from database version 14.23 (Homebrew)
+-- Dumped by pg_dump version 14.23 (Homebrew)
+
+SET statement_timeout = 0;
+SET lock_timeout = 0;
+SET idle_in_transaction_session_timeout = 0;
+SET client_encoding = 'UTF8';
+SET standard_conforming_strings = on;
+SELECT pg_catalog.set_config('search_path', '', false);
+SET check_function_bodies = false;
+SET xmloption = content;
+SET client_min_messages = warning;
+SET row_security = off;
+
+--
+-- Data for Name: medication; Type: TABLE DATA; Schema: public; Owner: macstudio3
+--
+
+COPY public.medication (id, user_id, person_id, name, generic_name, dosage, frequency, form, prescriber, pharmacy, rx_number, start_date, is_active, notes, metadata_jsonb, created_at, updated_at) FROM stdin;
+med_01kx1wz68gsw14nawwjzcc2gpd user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 ACCU-CHEK AVIVA PLUS STRP \N \N \N \N FARAHMANDIAN, DANNY Shangoo Pharmacy 447138 2023-07-18 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.449237-07 2026-07-08 15:18:26.449237-07
+med_01kx1wz68kqkv0bf80v9g8he3b user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 CREON CREON \N \N \N FARAH, DANNY Shangoo Pharmacy 468782 2023-07-18 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.451523-07 2026-07-08 15:18:26.451523-07
+med_01kx1wz68m1x0jcr8y3m8j4v24 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 HYDROCODON-APAP 10-325 HYDROCODONE \N \N \N ZHENG, JOHN Shangoo Pharmacy 463335 2023-07-18 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.452453-07 2026-07-08 15:18:26.452453-07
+med_01kx1wz68mcm41941k3x5qkmfy user_steve prsn_01kx1tgad06883c7sq78ty9p6m CELECOXIB 200 MG CAPS CELECOXIB 200MG \N \N FARAH, DANNY Shangoo Pharmacy 470808 2023-08-14 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.452817-07 2026-07-08 15:18:26.452817-07
+med_01kx1wz68nxc362yk8x149tns1 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 METHOCARBAMOL 750 MG TABS METHOCARBAMOL 750MG \N \N ZHENG, JOHN Shangoo Pharmacy 471315 2023-08-14 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.453156-07 2026-07-08 15:18:26.453156-07
+med_01kx1wz68nbd94p0wtb5033epv user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 GABAPENTIN 300 MG CAPS GABAPENTIN 300MG \N \N ZHENG, JOHN Shangoo Pharmacy 470785 2023-08-14 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.453481-07 2026-07-08 15:18:26.453481-07
+med_01kx1wz68nhy9fdxnm48575a5y user_steve prsn_01kx1tgad06883c7sq78ty9p6m FLUOXETINE HCL 20 MG CAPS FLUOXETINE 20MG \N \N FARAH, DANNY Shangoo Pharmacy 466156 2023-08-14 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.453909-07 2026-07-08 15:18:26.453909-07
+med_01kx1wz68p8vm6x5jg9h7r7d4d user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 PANTOPRAZOLE 40 MG TAB PANTOPRAZOLE 40MG \N \N FARAH, DANNY Shangoo Pharmacy 467690 2023-09-08 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.454162-07 2026-07-08 15:18:26.454162-07
+med_01kx1wz68pab2mxy6jqpy7t2y7 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 FOLIC ACID 1 MG TABS FOLIC ACID 1MG \N \N FARAH, DANNY Shangoo Pharmacy 471946 2023-09-08 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.45439-07 2026-07-08 15:18:26.45439-07
+med_01kx1wz68pqdmfb7z466j89f9d user_steve prsn_01kx1tgad06883c7sq78ty9p6m HYDROCODON-APAP 10-325 HYDROCODONE \N \N \N Manda, Kelly Michele Shangoo Pharmacy 457062 2023-12-07 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.454615-07 2026-07-08 15:18:26.454615-07
+med_01kx1wz68pfzwxa0x9hbcw6fe4 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 METFORMIN HCL 500 MG TABS METFORMIN 500MG \N \N FARAH, DANNY Shangoo Pharmacy 452042 2024-01-08 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.454873-07 2026-07-08 15:18:26.454873-07
+med_01kx1wz68qp885wznasv6d3vck user_steve prsn_01kx1tgad06883c7sq78ty9p6m TIZANIDINE HCL 4 MG TABS TIZANIDINE 4MG \N \N GULARTE, NICHOLAS Shangoo Pharmacy 453018 2024-02-09 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.455164-07 2026-07-08 15:18:26.455164-07
+med_01kx1wz68qy90y5epx0n25yx35 user_steve prsn_01kx1tgad06883c7sq78ty9p6m CELECOXIB 100 MG CAPS CELECOXIB 100MG \N \N ROSHAN, DANIEL Shangoo Pharmacy 454039 2024-03-22 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.455589-07 2026-07-08 15:18:26.455589-07
+med_01kx1wz68q5hs5rgtajtfkx8rb user_steve prsn_01kx1tgad06883c7sq78ty9p6m GABAPENTIN 300 MG CAPS GABAPENTIN 300MG \N \N FARAH, DANNY Shangoo Pharmacy 455042 2024-04-08 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.455857-07 2026-07-08 15:18:26.455857-07
+med_01kx1wz68r9kwnpb0bgr86w7j4 user_steve prsn_01kx1tgad06883c7sq78ty9p6m INDOMETHACIN 50 MG CAP INDOMETHACIN 50MG \N \N FARAH, DANNY Shangoo Pharmacy 454492 2024-04-10 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.456069-07 2026-07-08 15:18:26.456069-07
+med_01kx1wz68r2zk2vzytfayws9ab user_steve prsn_01kx1tgad06883c7sq78ty9p6m ATORVASTATIN CAL 20 MG ATORVASTATIN 20MG \N \N FARAH, DANNY Shangoo Pharmacy 469672 2024-04-19 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.456307-07 2026-07-08 15:18:26.456307-07
+med_01kx1wz68rbfpny7dxt43nztym user_steve prsn_01kx1tgad06883c7sq78ty9p6m CYCLOBENZAPRINE HCL 10-MG T CYCLOBENZAPRINE 10-MG \N \N FARAH, DANNY Shangoo Pharmacy 454635 2024-04-19 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.456557-07 2026-07-08 15:18:26.456557-07
+med_01kx1wz68s55t5t2v9yk20wc0f user_steve prsn_01kx1tgad06883c7sq78ty9p6m CYCLOBENZAPRINE HCL 10 MG T CYCLOBENZAPRINE 10MG \N \N FARAH, DANNY Shangoo Pharmacy 465849 2024-05-02 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.457118-07 2026-07-08 15:18:26.457118-07
+med_01kx1wz68s6sk7x61rjq6nwkrm user_steve prsn_01kx1tgad06883c7sq78ty9p6m OMEPRAZOLE 20 MG CPDR OMEPRAZOLE 20MG \N \N FARAH, DANNY Shangoo Pharmacy \N 2024-05-17 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.457386-07 2026-07-08 15:18:26.457386-07
+med_01kx1wz68sx8t99p4zqwppc7y5 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 FLUTICASONE PROP 50 MCG SPR FLUTICASONE 50MCG \N \N FARAH, DANNY Shangoo Pharmacy 455669 2024-05-30 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.457639-07 2026-07-08 15:18:26.457639-07
+med_01kx1wz68seksn669d54z5kea6 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 LORAZEPAM 0.5 MG TABS LORAZEPAM 0.5MG \N \N ZARAGOZA, GISELLE A. RODR Shangoo Pharmacy 461847 2025-01-15 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.45789-07 2026-07-08 15:18:26.45789-07
+med_01kx1wz68tzvrbcazn94z2mzq9 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 HYDROCODONE-APAP 5-325 MG HYDROCODONE 5-325MG \N \N ZHENG, JOHN Shangoo Pharmacy 472339 2025-05-06 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.458136-07 2026-07-08 15:18:26.458136-07
+med_01kx1wz68ta5de6sc5xjmztxxp user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 NA SULFATE-K SULFATE-MG SUL \N \N \N \N BASSERI, BENJAMIN Shangoo Pharmacy \N 2025-05-27 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.458334-07 2026-07-08 15:18:26.458334-07
+med_01kx1wz68ttfvytr3qch61s3ef user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 NYSTATIN NYSTATIN \N \N \N FARAH, DANNY Shangoo Pharmacy 467933 2025-08-21 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.45856-07 2026-07-08 15:18:26.45856-07
+med_01kx1wz68tna4pfdq0f3w03hft user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 FLUCONAZOLE 200 MG TABS FLUCONAZOLE 200MG \N \N BASSERI, BENJAMIN Shangoo Pharmacy 466843 2025-09-05 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.458806-07 2026-07-08 15:18:26.458806-07
+med_01kx1wz68t2jfzy584ps4peykf user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 GLUTOSE 5 40 % GEL \N 40% \N \N FARAH, DANNY Shangoo Pharmacy 467691 2025-10-16 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.459051-07 2026-07-08 15:18:26.459051-07
+med_01kx1wz68vzbbna5yskv33rqm7 user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 PROPRANOLOL HCL 20 MG TABS PROPRANOLOL 20MG \N \N FARAH, DANNY Shangoo Pharmacy 471945 2025-10-16 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.459324-07 2026-07-08 15:18:26.459324-07
+med_01kx1wz68v8p24drx8rtk0qs7m user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 ONDANSETRON 4 MG TAB ODT ONDANSETRON 4MG \N \N FARAH, DANNY Shangoo Pharmacy 467932 2025-10-28 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.459642-07 2026-07-08 15:18:26.459642-07
+med_01kx1wz68vng2gg8a6ya49hsqh user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 VANCOMYCIN HCL 125 MG CAPS VANCOMYCIN 125MG \N \N FARAH, DANNY Shangoo Pharmacy \N 2025-10-29 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.459946-07 2026-07-08 15:18:26.459946-07
+med_01kx1wz68wgp6931cm84fbsh9n user_steve prsn_01kx1tgad06883c7sq78ty9p6m HYDROCODONE-APAP 7.5-325 MG HYDROCODONE 7.5-325MG \N \N FARAH, DANNY Shangoo Pharmacy 472009 2026-03-31 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.460201-07 2026-07-08 15:18:26.460201-07
+med_01kx1wz68wdjveg0vtsw6pwk3d user_steve prsn_01kx1tgad06883c7sq78ty9p6m FLUOXETINE HCL 10 MG CAPS FLUOXETINE 10MG \N \N FARAH, DANNY Shangoo Pharmacy 470807 2026-03-31 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.460444-07 2026-07-08 15:18:26.460444-07
+med_01kx1wz68wb4xw0cmhzehy0xjz user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 METOCLOPRAMIDE HCL 5 MG TAB METOCLOPRAMIDE 5MG \N \N SANKHALA, KAMALESH KUMAR Shangoo Pharmacy 471019 2026-04-09 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.460729-07 2026-07-08 15:18:26.460729-07
+med_01kx1wz68x1fctsf3g5rkwdsah user_steve prsn_01kx1tgad5tqa7hjrq6exx1037 HYOSCYAMINE 0.125 MG ODT HYOSCYAMINE 0.125MG \N \N SANKHALA, KAMALESH KUMAR Shangoo Pharmacy 471020 2026-04-09 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.461056-07 2026-07-08 15:18:26.461056-07
+med_01kx1wz68x3nf9cpyrkzm7142r user_steve prsn_01kx1tgad06883c7sq78ty9p6m ANASTROZOLE 1 MG TABS ANASTROZOLE 1MG \N \N FARAH, DANNY Shangoo Pharmacy 471175 2026-04-17 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.461334-07 2026-07-08 15:18:26.461334-07
+med_01kx1wz68xsgmnrqtgd72v5777 user_steve prsn_01kx1tgad06883c7sq78ty9p6m CLOMIPHENE CITRATE 50 MG TA CLOMIPHENE 50MG \N \N FARAH, DANNY Shangoo Pharmacy 471174 2026-04-17 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.46174-07 2026-07-08 15:18:26.46174-07
+med_01kx1wz68yreetd9fexbtnh1w4 user_steve prsn_01kx1tgad06883c7sq78ty9p6m GABAPENTIN 100 MG CAPS GABAPENTIN 100MG \N \N FARAH, DANNY Shangoo Pharmacy \N 2026-06-01 t Auto-derived from Shangoo Pharmacy fill history. {} 2026-07-08 15:18:26.462107-07 2026-07-08 15:18:26.462107-07
+\.
+
+
+--
+-- Data for Name: medication_recall; Type: TABLE DATA; Schema: public; Owner: macstudio3
+--
+
+COPY public.medication_recall (id, user_id, medication_id, source, recall_number, classification, status, reason, product_description, recall_initiation_date, url, raw_jsonb, matched_at) FROM stdin;
+mrcl_01kx1wz70gy3tb8q44hxhkra98 user_steve med_01kx1wz68kqkv0bf80v9g8he3b openFDA D-0402-2021 Class II Terminated CGMP Deviations: Intermittent exposure to temperature excursion during storage. Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A. 2021-03-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0402-2021 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0300322637701", "0300320045706", "0300320047700", "0300320046703", "0300323016130", "0300322636704", "0300321224018"], "unii": ["3560D81V50", "YOJ58O116E", "8MYC33932O"], "route": ["ORAL"], "rxcui": ["855495", "855499", "855503", "863829", "863836", "863841", "1113042", "1113046", "1373325", "1373327"], "spl_id": ["94463229-9296-4640-854f-41d76386d312"], "brand_name": ["CREON"], "spl_set_id": ["073201aa-556d-4a70-918e-84e9616fd88d"], "package_ndc": ["0032-1203-70", "0032-1203-64", "0032-1206-07", "0032-1206-01", "0032-1206-56", "0032-1212-07", "0032-1212-01", "0032-1212-46", "0032-1212-13", "0032-1224-07", "0032-1224-01", "0032-1224-46", "0032-3016-28", "0032-3016-13", "0032-3016-50", "0032-3016-12", "0032-0045-70", "0032-0045-30", "0032-0046-30", "0032-0046-70", "0032-0047-30", "0032-0047-70", "0032-2636-70", "0032-2636-01", "0032-2636-30", "0032-2637-70", "0032-2637-01", "0032-2637-30"], "product_ndc": ["0032-0045", "0032-1203", "0032-1206", "0032-1212", "0032-1224", "0032-3016", "0032-0046", "0032-0047", "0032-2636", "0032-2637"], "generic_name": ["PANCRELIPASE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["PANCRELIPASE AMYLASE", "PANCRELIPASE LIPASE", "PANCRELIPASE PROTEASE"], "manufacturer_name": ["AbbVie Inc."], "application_number": ["BLA020725"], "is_original_packager": [true]}, "event_id": "87512", "address_1": "7000 Cardinal Pl", "address_2": "N/A", "code_info": "1139494", "postal_code": "43017-1091", "report_date": "20210602", "product_type": "Drugs", "recall_number": "D-0402-2021", "classification": "Class II", "recalling_firm": "Cardinal Health Inc.", "product_quantity": "1669 bottles", "termination_date": "20240617", "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.", "distribution_pattern": "FL, GA, SC", "recall_initiation_date": "20210315", "initial_firm_notification": "Letter", "center_classification_date": "20210524"} 2026-07-08 15:18:27.216919-07
+mrcl_01kx1wz70mpqzxa7m3hgsys2dg user_steve med_01kx1wz68kqkv0bf80v9g8he3b openFDA D-0755-2018 Class II Terminated Lack of Processing Controls. Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply 2018-04-03 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0755-2018 {"city": "Vicksburg", "state": "MS", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79748", "address_1": "100 Pear Orchard Dr Ste A", "address_2": "N/A", "code_info": "All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018", "postal_code": "39180-7153", "report_date": "20180516", "product_type": "Drugs", "recall_number": "D-0755-2018", "classification": "Class II", "recalling_firm": "Kroger Specialty Pharmacy, Inc.", "product_quantity": "Unknown", "termination_date": "20200507", "reason_for_recall": "Lack of Processing Controls.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply", "distribution_pattern": "MS, LA, AR, IL, FL", "recall_initiation_date": "20180403", "initial_firm_notification": "Letter", "center_classification_date": "20180510"} 2026-07-08 15:18:27.220188-07
+mrcl_01kx1wz70m37b7da9k1y3z716x user_steve med_01kx1wz68kqkv0bf80v9g8he3b openFDA D-1611-2014 Class II Terminated Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000. CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07. 2014-09-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1611-2014 {"city": "North Chicago", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0300322637701", "0300320045706", "0300320047700", "0300320046703", "0300323016130", "0300322636704", "0300321224018"], "unii": ["3560D81V50", "YOJ58O116E", "8MYC33932O"], "route": ["ORAL"], "rxcui": ["855495", "855499", "855503", "863829", "863836", "863841", "1113042", "1113046", "1373325", "1373327"], "spl_id": ["94463229-9296-4640-854f-41d76386d312"], "brand_name": ["CREON"], "spl_set_id": ["073201aa-556d-4a70-918e-84e9616fd88d"], "package_ndc": ["0032-1203-70", "0032-1203-64", "0032-1206-07", "0032-1206-01", "0032-1206-56", "0032-1212-07", "0032-1212-01", "0032-1212-46", "0032-1212-13", "0032-1224-07", "0032-1224-01", "0032-1224-46", "0032-3016-28", "0032-3016-13", "0032-3016-50", "0032-3016-12", "0032-0045-70", "0032-0045-30", "0032-0046-30", "0032-0046-70", "0032-0047-30", "0032-0047-70", "0032-2636-70", "0032-2636-01", "0032-2636-30", "0032-2637-70", "0032-2637-01", "0032-2637-30"], "product_ndc": ["0032-0045", "0032-1203", "0032-1206", "0032-1212", "0032-1224", "0032-3016", "0032-0046", "0032-0047", "0032-2636", "0032-2637"], "generic_name": ["PANCRELIPASE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["PANCRELIPASE AMYLASE", "PANCRELIPASE LIPASE", "PANCRELIPASE PROTEASE"], "manufacturer_name": ["AbbVie Inc."], "application_number": ["BLA020725"], "is_original_packager": [true]}, "event_id": "69285", "address_1": "1 N Waukegan Rd", "address_2": "N/A", "code_info": "Lot #: 1020156; Expiry: 3/31/2016", "postal_code": "60064", "report_date": "20141008", "product_type": "Drugs", "recall_number": "D-1611-2014", "classification": "Class II", "recalling_firm": "AbbVie Inc", "product_quantity": "18,021 Bottles", "termination_date": "20160622", "reason_for_recall": "Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.", "distribution_pattern": "US: Nationwide", "recall_initiation_date": "20140915", "initial_firm_notification": "Letter", "center_classification_date": "20140926"} 2026-07-08 15:18:27.220988-07
+mrcl_01kx1wz7c1js1g12stwm4sys0t user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-058-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. 2012-09-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-058-2013 {"city": "Corona", "state": "CA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63246", "address_1": "311 Bonnie Cir", "address_2": "N/A", "code_info": "Lot #: 519406A, 521759A, Exp 04/14", "postal_code": "92880-2882", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-058-2013", "classification": "Class I", "recalling_firm": "Watson Laboratories Inc", "product_quantity": "4,874 bottles", "termination_date": "20140324", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20120921", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:27.585271-07
+mrcl_01kx1wz7c2exkccfmx66pf1w0x user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-0599-2018 Class III Terminated Failed Impurities/Degradation Specifications Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038 2018-03-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2018 {"city": "Somerset", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0343386118038", "343386118038"], "unii": ["68JRS2HC1C", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["992656"], "spl_id": ["116df522-26b7-42de-8c0b-16cc60c2e764"], "brand_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "spl_set_id": ["41ac90b3-f007-4eb2-9d41-ea626ced2017"], "package_ndc": ["43386-118-03", "43386-118-01", "43386-118-05", "3433861180"], "product_ndc": ["43386-118"], "generic_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["HOMATROPINE METHYLBROMIDE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "application_number": ["ANDA091528"], "is_original_packager": [true]}, "event_id": "79298", "address_1": "400 Campus Dr", "address_2": "", "code_info": "M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);", "postal_code": "08873-1145", "report_date": "20180321", "product_type": "Drugs", "recall_number": "D-0599-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Novel Laboratories, Inc.", "product_quantity": "134,364 bottles (4,030,920 tablets)", "termination_date": "20200608", "reason_for_recall": "Failed Impurities/Degradation Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038", "distribution_pattern": "Nationwide", "recall_initiation_date": "20180305", "initial_firm_notification": "Letter", "center_classification_date": "20180314"} 2026-07-08 15:18:27.586121-07
+mrcl_01kx1wz7c2j7ewypxvrwr7dfpd user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-0276-2022 Class II Terminated Product Mix-up Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01. 2021-11-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2022 {"city": "Central Islip", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0331722997010", "0331722996013"], "unii": ["362O9ITL9D", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["856999", "857002"], "spl_id": ["d745e0ac-ee48-44c7-8430-8da0a69d2735"], "brand_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "spl_set_id": ["ed6af366-753c-4f3b-a6a2-c9a183c50035"], "package_ndc": ["31722-996-01", "31722-996-05", "31722-997-01", "31722-997-05"], "product_ndc": ["31722-996", "31722-997"], "generic_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ACETAMINOPHEN", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "application_number": ["ANDA211487"], "is_original_packager": [true]}, "event_id": "89060", "address_1": "400 S Technology Dr", "address_2": "N/A", "code_info": "Lot #: 21070817, Exp 6/2023", "postal_code": "11722-4402", "report_date": "20211215", "product_type": "Drugs", "recall_number": "D-0276-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Ascent Pharmaceuticals, Inc.", "product_quantity": "9744 bottles", "termination_date": "20231206", "reason_for_recall": "Product Mix-up", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20211119", "initial_firm_notification": "Letter", "center_classification_date": "20211207"} 2026-07-08 15:18:27.586582-07
+mrcl_01kx1wz7c3cn77p00krzwn88mv user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-1383-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1383-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18B013, Exp. 02/2020; 18E024; 18E030, Exp. 05/2020.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1383-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "11,112 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:27.58718-07
+mrcl_01kx1wz7c3ea174arpw09dpb8n user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-138-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. 2012-12-06 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-138-2013 {"city": "Huntsville", "state": "AL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63818", "address_1": "120 Vintage Dr NE", "address_2": "", "code_info": "Lot #: All that begin with the letter \\"C\\" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20130206", "product_type": "Drugs", "recall_number": "D-138-2013", "classification": "Class I", "more_code_info": "", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "897,379 bottles", "termination_date": "20210720", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20121206", "initial_firm_notification": "Press Release", "center_classification_date": "20130130"} 2026-07-08 15:18:27.587589-07
+mrcl_01kx1wz7c4wdgxx2kx6pf0tw74 user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-1384-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1384-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1384-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "7,728 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:27.588779-07
+mrcl_01kx1wz7c57hnkdyh6cwg3chrm user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-057-2013 Class I Ongoing Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 2012-09-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-057-2013 {"city": "Huntsville", "state": "AL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "63138", "address_1": "120 Vintage Dr NE", "address_2": "N/A", "code_info": "Lot number: C1440512A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-057-2013", "classification": "Class I", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "14,445 bottles", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21", "distribution_pattern": "Nationwide.", "recall_initiation_date": "20120910", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:27.589451-07
+mrcl_01kx1wz7c52xxbbey3yw79c6gq user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-1517-2019 Class II Terminated Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. 2019-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2019 {"city": "Monmouth Junction", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0327808086013"], "unii": ["V1Q0O9OJ9Z", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["1087459"], "spl_id": ["b3ac95d4-bef9-4e32-9822-73b9534c9869"], "brand_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "spl_set_id": ["25f400d9-1d6e-4d38-8f0d-98d471eba73b"], "package_ndc": ["27808-086-02", "27808-086-01", "27808-086-03"], "product_ndc": ["27808-086"], "generic_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["CHLORPHENIRAMINE MALEATE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "application_number": ["ANDA091632"], "is_original_packager": [true]}, "event_id": "83346", "address_1": "2033 US Highway 130", "address_2": "N/A", "code_info": "Lot#: 14079, Exp 10/2021", "postal_code": "08852-3003", "report_date": "20190731", "product_type": "Drugs", "recall_number": "D-1517-2019", "classification": "Class II", "recalling_firm": "Tris Pharma Inc.", "product_quantity": "2,550 bottles", "termination_date": "20211102", "reason_for_recall": "Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20190711", "initial_firm_notification": "Letter", "center_classification_date": "20190724"} 2026-07-08 15:18:27.589908-07
+mrcl_01kx1wz7c7kea9kgw01v1nqrck user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-609-2014 Class II Terminated Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014. HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-609-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg has the following code Pedigree: W004005, EXP: 7/1/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-609-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:27.591121-07
+mrcl_01kx1wz83ve2k6jzb6by4gxahv user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-0406-2021 Class II Terminated CGMP Deviations: Intermittent exposure to temperature excursion during storage. METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS 2021-03-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0406-2021 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "87512", "address_1": "7000 Cardinal Pl", "address_2": "N/A", "code_info": "UMETA0036A", "postal_code": "43017-1091", "report_date": "20210602", "product_type": "Drugs", "recall_number": "D-0406-2021", "classification": "Class II", "recalling_firm": "Cardinal Health Inc.", "product_quantity": "51 bottles", "termination_date": "20240617", "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS", "distribution_pattern": "FL, GA, SC", "recall_initiation_date": "20210315", "initial_firm_notification": "Letter", "center_classification_date": "20210524"} 2026-07-08 15:18:28.347317-07
+mrcl_01kx1wz7c79ww814skbfme3bz8 user_steve med_01kx1wz68m1x0jcr8y3m8j4v24 openFDA D-1139-2017 Class III Terminated Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16 2017-08-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2017 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77998", "address_1": "7265 Ulmerton Rd", "address_2": "N/A", "code_info": "Lot: 494700 Exp. 10/2018", "postal_code": "33771-4809", "report_date": "20170920", "product_type": "Drugs", "recall_number": "D-1139-2017", "classification": "Class III", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "3084 bottles", "termination_date": "20190311", "reason_for_recall": "Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16", "distribution_pattern": "Nationwide", "recall_initiation_date": "20170817", "initial_firm_notification": "Letter", "center_classification_date": "20170912"} 2026-07-08 15:18:27.591513-07
+mrcl_01kx1wz7rge0n5e2pwsy88n1v8 user_steve med_01kx1wz68mcm41941k3x5qkmfy openFDA D-0459-2025 Class II Ongoing Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71 2025-05-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0459-2025 {"city": "Panchmahal", "state": "", "status": "Ongoing", "country": "India", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0362332142309", "0362332143306", "0362332141302", "0362332140305"], "unii": ["JCX84Q7J1L"], "route": ["ORAL"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_id": ["0ae26abe-bbc0-48bf-b038-ca400ee197cd"], "brand_name": ["CELECOXIB"], "spl_set_id": ["806e5f8a-f986-4f88-ba3e-8265f86afa48"], "package_ndc": ["62332-140-30", "62332-140-60", "62332-140-91", "62332-140-08", "62332-141-30", "62332-141-31", "62332-141-91", "62332-141-08", "62332-141-60", "62332-141-71", "62332-142-30", "62332-142-31", "62332-142-91", "62332-142-71", "62332-142-08", "62332-142-60", "62332-143-30", "62332-143-60", "62332-143-71", "62332-143-10", "2405014780"], "product_ndc": ["62332-140", "62332-141", "62332-142", "62332-143"], "generic_name": ["CELECOXIB"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["CELECOXIB"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "application_number": ["ANDA204519"], "is_original_packager": [true]}, "event_id": "96840", "address_1": "Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol", "address_2": "", "code_info": "Batch 2405014780, Exp. Date: Sep. 30, 2027", "postal_code": "N/A", "report_date": "20250618", "product_type": "Drugs", "recall_number": "D-0459-2025", "classification": "Class II", "more_code_info": "", "recalling_firm": "Alembic Pharmaceuticals Limited", "product_quantity": "2,946 500-count bottles", "reason_for_recall": "Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71", "distribution_pattern": "Distributed Nationwide and in PR", "recall_initiation_date": "20250509", "initial_firm_notification": "Letter", "center_classification_date": "20250606"} 2026-07-08 15:18:27.98517-07
+mrcl_01kx1wz7rj9n5cr2cv6g0syjpz user_steve med_01kx1wz68mcm41941k3x5qkmfy openFDA D-0460-2025 Class II Ongoing Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15 2025-05-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0460-2025 {"city": "Pulaski", "state": "TN", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "route": ["ORAL"], "rxcui": ["205322", "205323"], "spl_id": ["5245a7d8-0271-b4bf-e063-6294a90a34a5"], "brand_name": ["CELECOXIB"], "spl_set_id": ["951df0f7-5fb7-40f5-e053-2995a90a1edd"], "package_ndc": ["50268-168-11", "50268-168-15", "50268-169-11", "50268-169-15"], "product_ndc": ["50268-168", "50268-169"], "generic_name": ["CELECOXIB"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["CELECOXIB"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"], "application_number": ["ANDA204519"], "original_packager_product_ndc": ["62332-141", "62332-142"]}, "event_id": "96888", "address_1": "615 N 1st St", "address_2": "", "code_info": "Lot #47881, Exp 05/31/2026", "postal_code": "38478-2403", "report_date": "20250618", "product_type": "Drugs", "recall_number": "D-0460-2025", "classification": "Class II", "more_code_info": "", "recalling_firm": "AvKARE", "product_quantity": "3,817 50-count cartons", "reason_for_recall": "Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20250513", "initial_firm_notification": "Letter", "center_classification_date": "20250609"} 2026-07-08 15:18:27.986253-07
+mrcl_01kx1wz7rj1mqdm676v1p832v4 user_steve med_01kx1wz68mcm41941k3x5qkmfy openFDA D-0478-2018 Class II Terminated CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 2018-02-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2018 {"city": "Waterford", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79149", "address_1": "6650 Highland Rd Ste 302", "address_2": "N/A", "code_info": "Lot #: a) 080515-2, Exp. 06/05/2019; b) 080515-1, Exp. 06/05/2019; c) 080515-1, Exp. 06/05/2019;", "postal_code": "48327-1665", "report_date": "20180228", "product_type": "Drugs", "recall_number": "D-0478-2018", "classification": "Class II", "recalling_firm": "American Pharmaceutical Ingredients LLC", "product_quantity": "48525 g", "termination_date": "20191202", "reason_for_recall": "CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327", "distribution_pattern": "Nationwide within USA.", "recall_initiation_date": "20180209", "initial_firm_notification": "Letter", "center_classification_date": "20180222"} 2026-07-08 15:18:27.987015-07
+mrcl_01kx1wz7rky9em0wafdj3fp7gg user_steve med_01kx1wz68mcm41941k3x5qkmfy openFDA D-570-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Celecoxib active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-570-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-570-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "2900 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:27.987532-07
+mrcl_01kx1wz83t5td6nxz8tgk93eqt user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-0400-2019 Class II Terminated Lack of sterility assurance. Methocarbamol liquid 100mg/ml, RX, glass vial 2019-01-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0400-2019 {"city": "Roseburg", "state": "OR", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "81883", "address_1": "1350 Ne Stephens St Ste 42", "address_2": "N/A", "code_info": "10082018@34 exp 1/6/19, 10312018@27 exp 1/29/19", "postal_code": "97470-6410", "report_date": "20190109", "product_type": "Drugs", "recall_number": "D-0400-2019", "classification": "Class II", "recalling_firm": "Hiers Enterprises, LLC dba Northwest Compounding Pharmacy", "product_quantity": "300 ml", "termination_date": "20230328", "reason_for_recall": "Lack of sterility assurance.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Methocarbamol liquid 100mg/ml, RX, glass vial", "distribution_pattern": "Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.", "recall_initiation_date": "20190102", "initial_firm_notification": "Letter", "center_classification_date": "20190127"} 2026-07-08 15:18:28.346418-07
+mrcl_01kx1wz83vgkr2gfh79qwb3q5t user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-0009-2019 Class I Terminated Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily." robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10. 2018-09-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2019 {"city": "Malvern", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "81034", "address_1": "1400 Atwater Dr", "address_2": "", "code_info": "Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21", "postal_code": "19355-8701", "report_date": "20181010", "product_type": "Drugs", "recall_number": "D-0009-2019", "classification": "Class I", "more_code_info": "", "recalling_firm": "Endo Pharmaceuticals, Inc.", "product_quantity": "2,856 bottles", "termination_date": "20200204", "reason_for_recall": "Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states \\"Two to four tablets four times daily.\\" rather than the correct dosage of \\"Two tablets three times daily.\\"", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.", "distribution_pattern": "Nationwide in the USA.", "recall_initiation_date": "20180917", "initial_firm_notification": "Letter", "center_classification_date": "20181009"} 2026-07-08 15:18:28.347996-07
+mrcl_01kx1wz83wmgg1v8zrraktt0f2 user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-430-2014 Class II Terminated Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 2013-10-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-430-2014 {"city": "South Lyon", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "66566", "address_1": "350 S Lafayette St", "address_2": "", "code_info": "All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@1", "postal_code": "48178-1814", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-430-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Specialty Medicine Compounding Pharmacy", "product_quantity": "20 mL", "termination_date": "20140922", "reason_for_recall": "Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178", "distribution_pattern": "Hospitals, clinics, physicians, and patients in the Michigan area only.", "recall_initiation_date": "20131019", "initial_firm_notification": "Press Release", "center_classification_date": "20140110"} 2026-07-08 15:18:28.348571-07
+mrcl_01kx1wz83x46dg2phbry57e7ek user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-0354-2025 Class II Ongoing Lack of Assurance of Sterility: Media fill with bacterial contamination Methocarbamol Injection USP\t1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton) 2025-03-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2025 {"city": "Bengaluru", "state": "N/A", "status": "Ongoing", "country": "India", "openfda": {"nui": ["N0000175730", "N0000175737"], "upc": ["0370069101018", "0370069101100", "0370069101254", "0370069101056"], "unii": ["125OD7737X"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["238175"], "spl_id": ["dd175ad9-9f83-4ef1-b745-65e44f5e12c4"], "brand_name": ["METHOCARBAMOL"], "spl_set_id": ["68dd9c24-4d41-48be-9f54-fceb787bb443"], "package_ndc": ["70069-101-25", "70069-101-10", "70069-101-05"], "product_ndc": ["70069-101"], "generic_name": ["METHOCARBAMOL"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "substance_name": ["METHOCARBAMOL"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "application_number": ["ANDA207522"], "is_original_packager": [true]}, "event_id": "96569", "address_1": "54/1 Budihal Village", "address_2": "N/A", "code_info": "NDC 70069-101-25; A240304, A240305, A240320, A240322, A240334, A240335, A240340, exp. date 05/2026; A240342, A240347, A240385, A240391, exp. date 06/2026; NDC 70069-101-05; A240326, exp. date 05/2026", "postal_code": "N/A", "report_date": "20250416", "product_type": "Drugs", "recall_number": "D-0354-2025", "classification": "Class II", "recalling_firm": "Somerset Therapeutics Private Limited", "product_quantity": "506,080 vials", "reason_for_recall": "Lack of Assurance of Sterility: Media fill with bacterial contamination", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Methocarbamol Injection USP\\t1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)", "distribution_pattern": "U.S. Nationwide", "recall_initiation_date": "20250321", "initial_firm_notification": "Letter", "center_classification_date": "20250408"} 2026-07-08 15:18:28.349226-07
+mrcl_01kx1wz83xv55cpt6xm63xj0r2 user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-784-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Methocarbamol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-784-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-784-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "250 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Methocarbamol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:28.349852-07
+mrcl_01kx1wz83y9s54hwjpfnf96k6v user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-1426-2015 Class III Terminated Presence of Foreign Substance: Presence of hair. METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05. 2015-08-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1426-2015 {"city": "Camarillo", "state": "CA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "71921", "address_1": "5187 Camino Ruiz", "address_2": "N/A", "code_info": "Lot # GS007849, Expiry: 02/2017", "postal_code": "93012-8601", "report_date": "20150916", "product_type": "Drugs", "recall_number": "D-1426-2015", "classification": "Class III", "recalling_firm": "Golden State Medical Supply Inc.", "product_quantity": "1,165 Bottles", "termination_date": "20151127", "reason_for_recall": "Presence of Foreign Substance: Presence of hair.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.", "distribution_pattern": "U.S. Including: GA.", "recall_initiation_date": "20150811", "initial_firm_notification": "Letter", "center_classification_date": "20150909"} 2026-07-08 15:18:28.350205-07
+mrcl_01kx1wz83y0fewk9zt3z2pn7k0 user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-0937-2017 Class II Terminated CGMP Deviations: Lack of quality assurance at the API manufacturer. Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 2017-05-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0937-2017 {"city": "Waterford", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77392", "address_1": "6650 Highland Rd Ste 302", "address_2": "N/A", "code_info": "Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18", "postal_code": "48327-1665", "report_date": "20170712", "product_type": "Drugs", "recall_number": "D-0937-2017", "classification": "Class II", "recalling_firm": "American Pharmaceutical Ingredients LLC", "product_quantity": "5,000g (5 kg)", "termination_date": "20180531", "reason_for_recall": "CGMP Deviations: Lack of quality assurance at the API manufacturer.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327", "distribution_pattern": "Nationwide", "recall_initiation_date": "20170526", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20170702"} 2026-07-08 15:18:28.350778-07
+mrcl_01kx1wz83zk4a7yn9x96c3j52r user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-866-2014 Class II Terminated Labeling: Label Mixup: METHOCARBAMOL, Tablet, 500 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 00093736498, Pedigree: AD46312_16, EXP: 5/16/2014. METHOCARBAMOL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143129001. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-866-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "METHOCARBAMOL, Tablet, 500 mg has the following codes: Pedigree: AD46312_28, EXP: 5/16/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-866-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: METHOCARBAMOL, Tablet, 500 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 00093736498, Pedigree: AD46312_16, EXP: 5/16/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METHOCARBAMOL, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00143129001.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:28.351188-07
+mrcl_01kx1wz83znk3k6eea75j5m6yz user_steve med_01kx1wz68nxc362yk8x149tns1 openFDA D-0440-2024 Class I Ongoing Presence of Particulate Matter Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10 2024-02-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0440-2024 {"city": "East Windsor", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["125OD7737X"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["238175"], "spl_id": ["980dbd07-e6d0-4d8a-8cbe-37c36c9e94c5"], "brand_name": ["METHOCARBAMOL"], "spl_set_id": ["e8e8da30-64cf-42ea-bf71-d085b0be8a09"], "package_ndc": ["55150-223-10"], "product_ndc": ["55150-223"], "generic_name": ["METHOCARBAMOL"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "substance_name": ["METHOCARBAMOL"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Eugia US LLC"], "application_number": ["ANDA206128"], "is_original_packager": [true]}, "event_id": "94025", "address_1": "279 Princeton Hightstown Rd", "address_2": "N/A", "code_info": "Lot #: 3MC23011, Exp 11/30/2026", "postal_code": "08520-1401", "report_date": "20240417", "product_type": "Drugs", "recall_number": "D-0440-2024", "classification": "Class I", "recalling_firm": "Eugia US LLC", "product_quantity": "1,552 10ml x 25/carton", "reason_for_recall": "Presence of Particulate Matter", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20240215", "initial_firm_notification": "Letter", "center_classification_date": "20240408"} 2026-07-08 15:18:28.351537-07
+mrcl_01kx1wz8f506axcyzm706y8n1n user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-0337-2015 Class II Terminated Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11 2014-12-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2015 {"city": "Elizabeth", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0731477272217"], "rxcui": ["310431"], "spl_id": ["b43e4780-f902-89d9-e053-2a95a90a6792"], "brand_name": ["GABA 300-EZS"], "spl_set_id": ["bb29692e-1546-4d05-a46a-93baf4172c7d"], "package_ndc": ["59088-725-00", "45963-556-11"], "product_ndc": ["59088-725"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "manufacturer_name": ["PureTek Corporation"], "is_original_packager": [true]}, "event_id": "70001", "address_1": "200 Elmora Ave", "address_2": "N/A", "code_info": "Lot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015", "postal_code": "07202-1106", "report_date": "20150114", "product_type": "Drugs", "recall_number": "D-0337-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Actavis Elizabeth LLC", "product_quantity": "24,240 Bottles", "termination_date": "20151120", "reason_for_recall": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11", "distribution_pattern": "Puerto Rico", "recall_initiation_date": "20141215", "initial_firm_notification": "Letter", "center_classification_date": "20150108"} 2026-07-08 15:18:28.709286-07
+mrcl_01kx1wz8f6cw6z6k12nc118ax9 user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-0354-2023 Class III Terminated Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05. 2023-02-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2023 {"city": "Hauppauge", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0350228180108", "0350228180054", "0350228181013", "0350228178013", "0350228181051", "0350228179010", "0350228180016", "0350228177016", "0350228179102", "0350228178051", "0350228177054"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["176515ec-fdba-417a-b849-86aea6fd7857"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["5ab9c18b-9568-4dcb-90b0-252aef8f8dc2"], "package_ndc": ["50228-177-30", "50228-177-01", "50228-177-05", "50228-178-30", "50228-178-01", "50228-178-05"], "product_ndc": ["50228-177", "50228-178"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "application_number": ["ANDA205101"], "is_original_packager": [true]}, "event_id": "91717", "address_1": "89 Arkay Dr", "address_2": "N/A", "code_info": "Lot # G177092, Exp. 11/24", "postal_code": "11788-3727", "report_date": "20230308", "product_type": "Drugs", "recall_number": "D-0354-2023", "classification": "Class III", "more_code_info": "", "recalling_firm": "Sciegen Pharmaceuticals Inc", "product_quantity": "4,392 bottles", "termination_date": "20240617", "reason_for_recall": "Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20230217", "initial_firm_notification": "Letter", "center_classification_date": "20230227"} 2026-07-08 15:18:28.710268-07
+mrcl_01kx1wz8f6bhtj7bmsqzab3b39 user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-0208-2020 Class II Terminated Lack of Assurance of Sterility S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx 2019-08-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0208-2020 {"city": "Mesa", "state": "AZ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "83669", "address_1": "6828 E Brown Rd Ste 101", "address_2": "N/A", "code_info": "Lot #: S07312019DH@15, Exp 8/31/19", "postal_code": "85207-3761", "report_date": "20191113", "product_type": "Drugs", "recall_number": "D-0208-2020", "classification": "Class II", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "product_quantity": "N/A", "termination_date": "20230413", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20190812", "initial_firm_notification": "Letter", "center_classification_date": "20191105"} 2026-07-08 15:18:28.710838-07
+mrcl_01kx1wz8w5xx3ppn5n99xt9jaj user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-0456-2025 Class II Completed CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) 2025-05-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0456-2025 {"city": "Basking Ridge", "state": "NJ", "status": "Completed", "country": "United States", "openfda": {"upc": ["0313668443301", "0313668473308"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["2532159", "2532163"], "spl_id": ["f8d8c930-c8f9-4186-92fa-6f7a5dabe083"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74"], "package_ndc": ["13668-443-74", "13668-443-10", "13668-443-01", "13668-443-30", "13668-443-91", "13668-473-10", "13668-473-74", "13668-473-30", "13668-473-01", "13668-473-91", "13668-473-70"], "product_ndc": ["13668-443", "13668-473"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "application_number": ["ANDA206937"], "is_original_packager": [true]}, "event_id": "96983", "address_1": "106 Allen Rd Ste 305", "address_2": "N/A", "code_info": "Lot# BDX6K001; Exp. Date: 06/30/2025", "postal_code": "07920-3851", "report_date": "20250611", "product_type": "Drugs", "recall_number": "D-0456-2025", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc.", "product_quantity": "972 Cartons", "reason_for_recall": "CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)", "distribution_pattern": "U.S. Nationwide.", "recall_initiation_date": "20250527", "initial_firm_notification": "E-Mail", "center_classification_date": "20250602"} 2026-07-08 15:18:29.125704-07
+mrcl_01kx1wzafbvzcd8dbhfcbnrh9p user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-1349-2020 Class II Ongoing CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10 2020-05-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1349-2020 {"city": "Brookhaven", "state": "NY", "status": "Ongoing", "country": "United States", "openfda": {"upc": ["0365162178104", "0365162179101"], "unii": ["786Z46389E"], "route": ["ORAL"], "rxcui": ["860975", "860981"], "spl_id": ["984302ad-793e-4f35-92da-e5e7f92154f6"], "brand_name": ["METFORMIN HYDROCHLORIDE"], "spl_set_id": ["c01a79e0-f2b7-4d99-857e-bda7f24fe319"], "package_ndc": ["65162-178-89", "65162-178-03", "65162-178-09", "65162-178-10", "65162-178-50", "65162-178-11", "65162-179-03", "65162-179-09", "65162-179-10", "65162-179-50"], "product_ndc": ["65162-178", "65162-179"], "generic_name": ["METFORMIN HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METFORMIN HYDROCHLORIDE"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "application_number": ["ANDA078596"], "is_original_packager": [true]}, "event_id": "85781", "address_1": "50 Horseblock Rd", "address_2": "N/A", "code_info": "AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273A 10/31/2021 AM191274A 10/31/2021 AM191338A 11/30/2021 AM191339A 11/30/2021 AM191340A 11/30/2021 AM191341 12/31/2021 AM191342 12/31/2021 AM200109 12/31/2021 AM200110 12/31/2021 AM200111 12/31/2021", "postal_code": "11719-9509", "report_date": "20200701", "product_type": "Drugs", "recall_number": "D-1349-2020", "classification": "Class II", "recalling_firm": "Amneal Pharmaceuticals of New York, LLC", "product_quantity": "N/A", "reason_for_recall": "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10", "distribution_pattern": "Nationwide", "recall_initiation_date": "20200529", "initial_firm_notification": "Press Release", "center_classification_date": "20200625"} 2026-07-08 15:18:30.763861-07
+mrcl_01kx1wz8f717pxcaswk34gbjpn user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-1232-2020 Class II Terminated CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99 2020-03-18 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1232-2020 {"city": "East Windsor", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["7a45ad84-02a4-442d-8401-1a1495d084fa"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["1a619a14-0b63-4cba-80e7-474c9a1c90b9"], "package_ndc": ["65862-198-01", "65862-198-05", "65862-198-99", "65862-198-10", "65862-198-90", "65862-198-18", "65862-198-27", "65862-199-01", "65862-199-05", "65862-199-99", "65862-199-10", "65862-199-30", "65862-199-60", "65862-199-90", "65862-199-18", "65862-199-27", "65862-200-01", "65862-200-05", "65862-200-10", "65862-200-90", "65862-200-27"], "product_ndc": ["65862-198", "65862-199", "65862-200"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Aurobindo Pharma Limited"], "application_number": ["ANDA078787"], "is_original_packager": [true]}, "event_id": "85183", "address_1": "279 Princeton Hightstown Rd", "address_2": "", "code_info": "Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021", "postal_code": "08520-1401", "report_date": "20200422", "product_type": "Drugs", "recall_number": "D-1232-2020", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aurobindo Pharma USA Inc.", "product_quantity": "26625 units", "termination_date": "20240325", "reason_for_recall": "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99", "distribution_pattern": "Nationwide within the United States", "recall_initiation_date": "20200318", "initial_firm_notification": "Letter", "center_classification_date": "20200413"} 2026-07-08 15:18:28.711233-07
+mrcl_01kx1wz8f7y7t1mth9sz04jx16 user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-696-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Gabapentin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-696-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-696-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "365402 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:28.711688-07
+mrcl_01kx1wz8f89wdrkm8tz7wwnctn user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-0031-2026 Class II Ongoing Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). 2025-10-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0031-2026 {"city": "Dublin", "state": "OH", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0055154336307", "0055154799201"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["b6880b32-3ebc-4b0e-8a84-d513f3e401af", "b64683a2-7521-4a16-8fc7-4974606e2e3b"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["36f74fdf-0dae-47a0-a7ea-e64ac91cd88f", "41844c21-9e2a-4332-a8ff-9b71ae9032b0"], "package_ndc": ["0904-6665-61", "0904-6666-61", "0904-6667-61", "55154-3363-0", "55154-7992-0", "55154-7993-0"], "product_ndc": ["0904-6665", "0904-6666", "0904-6667", "55154-3363", "55154-7992", "55154-7993"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Major Pharmaceuticals", "Cardinal Health 107, LLC"], "application_number": ["ANDA090858"], "original_packager_product_ndc": ["67877-222", "67877-223", "67877-224", "0904-6665", "0904-6666", "0904-6667"]}, "event_id": "97777", "address_1": "7000 Cardinal Pl", "address_2": "", "code_info": "Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.", "postal_code": "43017-1091", "report_date": "20251029", "product_type": "Drugs", "recall_number": "D-0031-2026", "classification": "Class II", "more_code_info": "", "recalling_firm": "The Harvard Drug Group LLC", "product_quantity": "", "reason_for_recall": "Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).", "distribution_pattern": "US Nationwide.", "recall_initiation_date": "20251010", "initial_firm_notification": "", "center_classification_date": "20251017"} 2026-07-08 15:18:28.712107-07
+mrcl_01kx1wz8f8acpgnzqcgp3z4sh6 user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-0320-2025 Class II Ongoing CGMP Deviations Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05. 2025-03-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2025 {"city": "Mahwah", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0368462127018", "0368462126011"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["4da1bae0-701b-4b65-a01e-f4bcedfad849"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["3865a6e3-112c-490c-82ac-35401336b16e"], "package_ndc": ["68462-126-01", "68462-126-05", "68462-127-01", "68462-127-05"], "product_ndc": ["68462-126", "68462-127"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA077662"], "is_original_packager": [true]}, "event_id": "96474", "address_1": "750 Corporate Dr", "address_2": "N/A", "code_info": "Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25", "postal_code": "07430-2009", "report_date": "20250416", "product_type": "Drugs", "recall_number": "D-0320-2025", "classification": "Class II", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "product_quantity": "N/A", "reason_for_recall": "CGMP Deviations", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.", "distribution_pattern": "U.S. Nationwide", "recall_initiation_date": "20250313", "initial_firm_notification": "Letter", "center_classification_date": "20250408"} 2026-07-08 15:18:28.712697-07
+mrcl_01kx1wz8f9x73wkpxm2ywpes2t user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-0312-2025 Class III Ongoing Cross Contamination Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. 2025-03-04 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0312-2025 {"city": "Princeton", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0362756204010", "0362756202016", "0362756138025", "0362756137028", "0362756139022"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "spl_id": ["aff50a15-df39-495f-a145-0ba59660eed8"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["c9a05f0c-b5f0-422c-9d67-6d0efc921a74"], "package_ndc": ["62756-137-02", "62756-137-03", "62756-137-05", "62756-137-04", "62756-137-01", "62756-138-02", "62756-138-03", "62756-138-05", "62756-138-04", "62756-138-01", "62756-139-02", "62756-139-03", "62756-139-05", "62756-139-04", "62756-139-01", "62756-202-01", "62756-202-03", "62756-204-01", "62756-204-03"], "product_ndc": ["62756-137", "62756-138", "62756-139", "62756-202", "62756-204"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "application_number": ["ANDA077242"], "is_original_packager": [true]}, "event_id": "96415", "address_1": "2 Independence Way", "address_2": "N/A", "code_info": "Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025", "postal_code": "08540-6620", "report_date": "20250416", "product_type": "Drugs", "recall_number": "D-0312-2025", "classification": "Class III", "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "product_quantity": "852 bottles", "reason_for_recall": "Cross Contamination", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20250304", "initial_firm_notification": "Letter", "center_classification_date": "20250404"} 2026-07-08 15:18:28.7134-07
+mrcl_01kx1wz8fa1netc3ah8gcnp0f5 user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-329-2013 Class III Terminated Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. 2013-04-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-329-2013 {"city": "Mahwah", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0368462127018", "0368462126011"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["4da1bae0-701b-4b65-a01e-f4bcedfad849"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["3865a6e3-112c-490c-82ac-35401336b16e"], "package_ndc": ["68462-126-01", "68462-126-05", "68462-127-01", "68462-127-05"], "product_ndc": ["68462-126", "68462-127"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA077662"], "is_original_packager": [true]}, "event_id": "64995", "address_1": "750 Corporate Dr", "address_2": "", "code_info": "a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp 10/14 Lot# 02123430, Exp 10/14 Lot# 02123492, Exp 10/14 Lot# 02123523, Exp 10/14 Lot# 02123527, Exp 10/14 Lot# 02123532, Exp 10/14 Lot# 02123542, Exp 10/14 Lot# 02123546, Exp 10/14 Lot# 02123551, Exp 10/14 Lot# 02123555, Exp 10/14 Lot# 02123560, Exp 11/14 Lot# 02123566, Exp 11/14 Lot# 02123569, Exp 11/14 b) 800 mg Lot# 02123440 Exp 10/14 Lot# 02123445 Exp 10/14 Lot# 02123454 Exp 10/14 Lot# 02123465 Exp 10/14 Lot# 02123789 Exp 11/14 Lot# 02123804 Exp 11/14 Lot# 02123821 Exp 11/14 Lot# 02123829 Exp 11/14 Lot# 02123834 Exp 11/14 Lot# 02123841 Exp 11/14 Lot# 02123845 Exp 11/14", "postal_code": "07430-2009", "report_date": "20130522", "product_type": "Drugs", "recall_number": "D-329-2013", "classification": "Class III", "more_code_info": "", "recalling_firm": "Glenmark Generics Inc., USA", "product_quantity": "a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)", "termination_date": "20141009", "reason_for_recall": "Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20130405", "initial_firm_notification": "Letter", "center_classification_date": "20130516"} 2026-07-08 15:18:28.714215-07
+mrcl_01kx1wz8fa4cdh4qxd4aa9jb9j user_steve med_01kx1wz68nbd94p0wtb5033epv openFDA D-0336-2015 Class II Terminated Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA. 2014-12-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2015 {"city": "Elizabeth", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0345963555113", "0345963556110"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["63f9a25b-d34f-4b4b-8ccd-e0f6dac569f5"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["5969871e-6c71-4c37-9d63-370718ccc80c"], "package_ndc": ["45963-555-11", "45963-555-50", "45963-556-11", "45963-556-50", "45963-557-11", "45963-557-50", "14550-513-02"], "product_ndc": ["45963-555", "45963-556", "45963-557"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Actavis Pharma, Inc."], "application_number": ["ANDA075350"], "is_original_packager": [true]}, "event_id": "70001", "address_1": "200 Elmora Ave", "address_2": "N/A", "code_info": "Lot #s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015", "postal_code": "07202-1106", "report_date": "20150114", "product_type": "Drugs", "recall_number": "D-0336-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Actavis Elizabeth LLC", "product_quantity": "10,857 Bottles", "termination_date": "20151120", "reason_for_recall": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.", "distribution_pattern": "Puerto Rico", "recall_initiation_date": "20141215", "initial_firm_notification": "Letter", "center_classification_date": "20150108"} 2026-07-08 15:18:28.714701-07
+mrcl_01kx1wz8w4a9h9nwpyg9d0dpb2 user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-0971-2015 Class II Terminated Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960 2015-04-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0971-2015 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "70976", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015.", "postal_code": "19044-1220", "report_date": "20150506", "product_type": "Drugs", "recall_number": "D-0971-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "", "termination_date": "20161027", "reason_for_recall": "Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150413", "initial_firm_notification": "Letter", "center_classification_date": "20150427"} 2026-07-08 15:18:29.124903-07
+mrcl_01kx1wz8w6fkc5stqewxekcj1a user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-0291-2015 Class III Terminated Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule. Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01 2014-12-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0291-2015 {"city": "Broomfield", "state": "CO", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "69942", "address_1": "2555 W Midway Blvd", "address_2": "N/A", "code_info": "Lot ET5122, Exp. 10/17", "postal_code": "80020-1632", "report_date": "20141217", "product_type": "Drugs", "recall_number": "D-0291-2015", "classification": "Class III", "recalling_firm": "Sandoz Incorporated", "product_quantity": "1,008 bottles", "termination_date": "20150624", "reason_for_recall": "Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01", "distribution_pattern": "AZ", "recall_initiation_date": "20141205", "initial_firm_notification": "Letter", "center_classification_date": "20141209"} 2026-07-08 15:18:29.126515-07
+mrcl_01kx1wz8w67r4wjewwj2pdq1y1 user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-1280-2014 Class II Terminated Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. 2014-02-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1280-2014 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "67563", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15", "postal_code": "19044-1220", "report_date": "20140507", "product_type": "Drugs", "recall_number": "D-1280-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "257904 bottles", "termination_date": "20141215", "reason_for_recall": "Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20140212", "initial_firm_notification": "Letter", "center_classification_date": "20140428"} 2026-07-08 15:18:29.12707-07
+mrcl_01kx1wz8w92sq4kav7yhq4wv8h user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-0578-2018 Class III Terminated Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities. Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56 2018-02-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0578-2018 {"city": "North Wales", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79118", "address_1": "1090 Horsham Rd", "address_2": "", "code_info": "All lots within expiry.", "postal_code": "19454-1505", "report_date": "20180221", "product_type": "Drugs", "recall_number": "D-0578-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "1,157,095 bottles", "termination_date": "20190430", "reason_for_recall": "Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56", "distribution_pattern": "Distributed throughout the United States", "recall_initiation_date": "20180205", "initial_firm_notification": "Letter", "center_classification_date": "20180305"} 2026-07-08 15:18:29.129503-07
+mrcl_01kx1wz8w9pyhwdb6tmgxqfcvq user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-1281-2014 Class II Terminated Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5. 2014-02-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2014 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"upc": ["350111647015"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "67563", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15", "postal_code": "19044-1220", "report_date": "20140507", "product_type": "Drugs", "recall_number": "D-1281-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "72,356 bottles", "termination_date": "20141215", "reason_for_recall": "Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20140212", "initial_firm_notification": "Letter", "center_classification_date": "20140428"} 2026-07-08 15:18:29.13003-07
+mrcl_01kx1wz8wajpt6xzhxkc8r7r0d user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-1279-2014 Class II Terminated Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. 2014-02-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1279-2014 {"city": "Earth City", "state": "MO", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0368645130545", "368645130545"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["4c222d2c-813c-5520-e063-6294a90affe6"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["b07f9eab-44ac-4667-bd46-52d736daa5d6"], "package_ndc": ["68645-131-54", "68645-130-54"], "product_ndc": ["68645-130", "68645-131"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"], "application_number": ["ANDA076001"], "original_packager_product_ndc": ["50111-647", "50111-648"]}, "event_id": "67526", "address_1": "13333 Lakefront Dr", "address_2": "", "code_info": "Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15", "postal_code": "63045-1514", "report_date": "20140507", "product_type": "Drugs", "recall_number": "D-1279-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Legacy Pharmaceutical Packaging", "product_quantity": "667,068 bottles", "termination_date": "20171127", "reason_for_recall": "Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20140214", "initial_firm_notification": "Telephone", "center_classification_date": "20140428"} 2026-07-08 15:18:29.130495-07
+mrcl_01kx1wz99f0p61v56arvq1xans user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-0251-2021 Class III Terminated Failed Impurity/Degradation Specifications Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40 2021-02-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2021 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0362756129405"], "unii": ["6871619Q5X"], "route": ["INTRAVENOUS"], "rxcui": ["283669"], "spl_id": ["ef1bb9ed-b534-4698-abf5-836dcce85f45"], "brand_name": ["PANTOPRAZOLE SODIUM"], "spl_set_id": ["d9fcf6a2-3788-4955-84d9-3c319b13267c"], "package_ndc": ["62756-129-40", "62756-129-44", "62756-129-45"], "product_ndc": ["62756-129"], "generic_name": ["PANTOPRAZOLE SODIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["PANTOPRAZOLE SODIUM"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "application_number": ["ANDA077674"], "is_original_packager": [true]}, "event_id": "87260", "address_1": "2 Independence Way", "address_2": "N/A", "code_info": "JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021", "postal_code": "08540-6620", "report_date": "20210217", "product_type": "Drugs", "recall_number": "D-0251-2021", "classification": "Class III", "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "product_quantity": "20,475 vials", "termination_date": "20211103", "reason_for_recall": "Failed Impurity/Degradation Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40", "distribution_pattern": "Nationwide", "recall_initiation_date": "20210205", "initial_firm_notification": "Letter", "center_classification_date": "20210209"} 2026-07-08 15:18:29.551384-07
+mrcl_01kx1wzawkmjk8xwv4djhppw1t user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-0923-2023 Class II Ongoing Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 2023-06-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0923-2023 {"city": "Ranasthalam Mandal, Srikakulam", "state": "N/A", "status": "Ongoing", "country": "India", "openfda": {"upc": ["0355111180104", "0355111179108"], "unii": ["B53E3NMY5C"], "route": ["ORAL"], "rxcui": ["313412", "313413"], "spl_id": ["386ec98d-4a47-b025-b050-7e4ebce382c6"], "brand_name": ["TIZANIDINE"], "spl_set_id": ["a42f3479-f2c2-8214-d547-c5cae9bfed1e"], "package_ndc": ["55111-179-30", "55111-179-15", "55111-179-03", "55111-179-10", "55111-180-30", "55111-180-15", "55111-180-03", "55111-180-10"], "product_ndc": ["55111-179", "55111-180"], "generic_name": ["TIZANIDINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["TIZANIDINE HYDROCHLORIDE"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "application_number": ["ANDA076286"], "is_original_packager": [true]}, "event_id": "92564", "address_1": "Fto-Sez Unit 1, Surv. 57-59,60, 62 & 72", "address_2": "Sect. 9-14, 17-20, Devunipalavalasa", "code_info": "Lot: T2100585, T2100586, T2100587, Exp 12/2023", "postal_code": "N/A", "report_date": "20230726", "product_type": "Drugs", "recall_number": "D-0923-2023", "classification": "Class II", "more_code_info": "", "recalling_firm": "Dr Reddy's Laboratories Limited", "product_quantity": "17,548 1000-countbottles", "reason_for_recall": "Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.", "voluntary_mandated": "N/A", "product_description": "Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20230621", "initial_firm_notification": "N/A", "center_classification_date": "20230717"} 2026-07-08 15:18:31.187888-07
+mrcl_01kx1wz8waaerta1hhce1ab95m user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-517-2014 Class II Terminated Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014. FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-517-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "FLUoxetine HCl, Capsule, 10 mg has the following code Pedigree: AD70585_13, EXP: 5/29/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-517-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Capsules", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:29.130907-07
+mrcl_01kx1wz8wb0t9mgj6bhag7f5jj user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-0970-2015 Class II Terminated Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01 2015-04-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0970-2015 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "70976", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: 6A207012, Exp 7/2015.", "postal_code": "19044-1220", "report_date": "20150506", "product_type": "Drugs", "recall_number": "D-0970-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "", "termination_date": "20161027", "reason_for_recall": "Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150413", "initial_firm_notification": "Letter", "center_classification_date": "20150427"} 2026-07-08 15:18:29.131336-07
+mrcl_01kx1wz8wc3nsdwc4t4hhb39xg user_steve med_01kx1wz68nhy9fdxnm48575a5y openFDA D-0455-2025 Class II Completed CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 2025-05-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0455-2025 {"city": "Basking Ridge", "state": "NJ", "status": "Completed", "country": "United States", "openfda": {"upc": ["0313668443301", "0313668473308"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["2532159", "2532163"], "spl_id": ["f8d8c930-c8f9-4186-92fa-6f7a5dabe083"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74"], "package_ndc": ["13668-443-74", "13668-443-10", "13668-443-01", "13668-443-30", "13668-443-91", "13668-473-10", "13668-473-74", "13668-473-30", "13668-473-01", "13668-473-91"], "product_ndc": ["13668-443", "13668-473"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "application_number": ["ANDA206937"], "is_original_packager": [true]}, "event_id": "96983", "address_1": "106 Allen Rd Ste 305", "address_2": "N/A", "code_info": "Lot# BDX6K001; Exp. Date 06/30/2025", "postal_code": "07920-3851", "report_date": "20250611", "product_type": "Drugs", "recall_number": "D-0455-2025", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc.", "product_quantity": "3672 Bottles", "reason_for_recall": "CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30", "distribution_pattern": "U.S. Nationwide.", "recall_initiation_date": "20250527", "initial_firm_notification": "E-Mail", "center_classification_date": "20250602"} 2026-07-08 15:18:29.132231-07
+mrcl_01kx1wz99a69cxz3f4an63jhdt user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-1074-2019 Class II Terminated Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets. Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. 2019-03-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1074-2019 {"city": "Salisbury", "state": "MD", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82523", "address_1": "207 Kiley Dr", "address_2": "N/A", "code_info": "Lot #: PA217060A, Exp 05/2020", "postal_code": "21801-2249", "report_date": "20190410", "product_type": "Drugs", "recall_number": "D-1074-2019", "classification": "Class II", "recalling_firm": "Jubilant Cadista Pharmaceuticals, Inc.", "product_quantity": "12,960 bottles", "termination_date": "20190920", "reason_for_recall": "Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.", "distribution_pattern": "Nationwide in the USA.", "recall_initiation_date": "20190329", "initial_firm_notification": "Letter", "center_classification_date": "20190401"} 2026-07-08 15:18:29.546801-07
+mrcl_01kx1wz99bqvrq3pjaf77dgwx9 user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-1499-2016 Class II Terminated Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole. Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90 2016-08-03 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1499-2016 {"city": "Plainsboro", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "74949", "address_1": "666 Plainsboro Rd Ste 210", "address_2": "N/A", "code_info": "PSSB16011-A, Exp 01/18", "postal_code": "08536-3004", "report_date": "20160921", "product_type": "Drugs", "recall_number": "D-1499-2016", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aurobindo Pharma USA Inc", "product_quantity": "23016 bottles", "termination_date": "20180608", "reason_for_recall": "Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90", "distribution_pattern": "CA", "recall_initiation_date": "20160803", "initial_firm_notification": "Letter", "center_classification_date": "20160914"} 2026-07-08 15:18:29.547779-07
+mrcl_01kx1wz9ptfvv1s9n4z23p208g user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-0220-2020 Class II Terminated Lack of Assurance of Sterility S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX. 2019-08-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0220-2020 {"city": "Mesa", "state": "AZ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "83669", "address_1": "6828 E Brown Rd Ste 101", "address_2": "N/A", "code_info": "Lot #: S06162019DH@09, Exp 9/16/19; S06032019DT@01, Exp 9/30/19;", "postal_code": "85207-3761", "report_date": "20191113", "product_type": "Drugs", "recall_number": "D-0220-2020", "classification": "Class II", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "product_quantity": "5x30 ml glass vials", "termination_date": "20230413", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20190812", "initial_firm_notification": "Letter", "center_classification_date": "20191105"} 2026-07-08 15:18:29.978974-07
+mrcl_01kx1wz99czjdq7k10m676pkfy user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-689-2014 Class II Terminated Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014. PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-689-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PANTOPRAZOLE SODIUM DR Tablet, 20 mg has the following codes Pedigree: AD70690_4, EXP: 5/29/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-689-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "90 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:29.548312-07
+mrcl_01kx1wz99cqf9qzq3y6rn81emx user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-0540-2023 Class II Completed CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures. Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial). 2023-04-07 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0540-2023 {"city": "Coral Springs", "state": "FL", "status": "Completed", "country": "United States", "openfda": {}, "event_id": "92113", "address_1": "11772 W Sample Rd Ste 101", "address_2": "N/A", "code_info": "Lots: 220801; 220802; 220803 Exp. July 2024", "postal_code": "33065-3166", "report_date": "20230503", "product_type": "Drugs", "recall_number": "D-0540-2023", "classification": "Class II", "recalling_firm": "Methapharm Inc", "product_quantity": "5377 cartons", "reason_for_recall": "CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20230407", "initial_firm_notification": "Letter", "center_classification_date": "20230421"} 2026-07-08 15:18:29.548851-07
+mrcl_01kx1wz99d7ggz6s0n3sdtm692 user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-778-2014 Class II Terminated Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014. PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008060601. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-778-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PANTOPRAZOLE SODIUM DR, Tablet, 20 mg has the following codes: Pedigree: AD60272_28, EXP: 5/22/2014; Pedigree: AD73525_19, EXP: 5/30/2014", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-778-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "180 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008060601.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:29.549548-07
+mrcl_01kx1wz99ecs51jb2b4zq5t2m1 user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-1104-2022 Class II Terminated cGMP deviations: Temperature abuse Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95 2022-04-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1104-2022 {"city": "Richmond", "state": "VA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "89646", "address_1": "9954 Maryland Drive", "address_2": "Deep Run Iii Ste. 4000", "code_info": "McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.", "postal_code": "23233", "report_date": "20220615", "product_type": "Drugs", "recall_number": "D-1104-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office", "product_quantity": "1 carton/10 vials", "termination_date": "20231130", "reason_for_recall": "cGMP deviations: Temperature abuse", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95", "distribution_pattern": "USA nationwide.", "recall_initiation_date": "20220413", "initial_firm_notification": "Letter", "center_classification_date": "20220609"} 2026-07-08 15:18:29.550336-07
+mrcl_01kx1wz99eacqe48vt7mx47j3j user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-0516-2017 Class III Terminated Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25). 2016-11-22 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2017 {"city": "New York", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"unii": ["6871619Q5X"], "route": ["INTRAVENOUS"], "rxcui": ["283669", "885257"], "spl_id": ["a7e7d657-a748-4234-8dd6-c0e4d0f81a86", "d36cd2fb-517f-44e5-8438-53e563775f86"], "brand_name": ["PROTONIX"], "spl_set_id": ["51e4144a-489e-436c-609a-39305f8f56ba", "f39b3e7d-39d2-4c8a-9974-4ab885241880"], "package_ndc": ["0008-0923-51", "0008-0923-60", "0008-0923-55", "0008-4001-01", "0008-4001-10", "0008-4001-25", "00008-0941-01", "0008-0941-03"], "product_ndc": ["0008-0923", "0008-4001"], "generic_name": ["PANTOPRAZOLE SODIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["PANTOPRAZOLE SODIUM"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "application_number": ["NDA020988"], "is_original_packager": [true]}, "event_id": "75871", "address_1": "235 East 42nd Street", "address_2": "N/A", "code_info": "Lot #: A) a) 325449, Exp 12/16; b) N97969, N69175, N69177, Exp 03/17; N95727, Exp 04/17; B) M51076, Exp 11/16; and C) a) 317364, Exp 11/16; b) N73763, Exp 03/17", "postal_code": "10017-5703", "report_date": "20170322", "product_type": "Drugs", "recall_number": "D-0516-2017", "classification": "Class III", "recalling_firm": "Pfizer Inc.", "product_quantity": "582,165 vials", "termination_date": "20180622", "reason_for_recall": "Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).", "distribution_pattern": "Nationwide", "recall_initiation_date": "20161122", "initial_firm_notification": "Letter", "center_classification_date": "20170310"} 2026-07-08 15:18:29.550827-07
+mrcl_01kx1wz99fx1sem5akws6efebh user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-296-2013 Class II Terminated cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices. Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90 2013-02-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-296-2013 {"city": "Salisbury", "state": "MD", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "64869", "address_1": "207 Kiley Dr", "address_2": "", "code_info": "Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014", "postal_code": "21801-2249", "report_date": "20130508", "product_type": "Drugs", "recall_number": "D-296-2013", "classification": "Class II", "more_code_info": "", "recalling_firm": "Jubilant Cadista Pharmaceuticals Inc.", "product_quantity": "12770 bottles", "termination_date": "20131223", "reason_for_recall": "cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90", "distribution_pattern": "Nationwide", "recall_initiation_date": "20130211", "initial_firm_notification": "", "center_classification_date": "20130426"} 2026-07-08 15:18:29.551784-07
+mrcl_01kx1wz99g00t7gy98xsqwzy1p user_steve med_01kx1wz68p8vm6x5jg9h7r7d4d openFDA D-0313-2023 Class II Terminated Lack of sterility assurance PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 2022-12-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0313-2023 {"city": "Chesapeake", "state": "VA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "91466", "address_1": "535 Independence Pkwy Ste 300", "address_2": "N/A", "code_info": "Beyond Use Date: December 29, 2022", "postal_code": "23320-5176", "report_date": "20230222", "product_type": "Drugs", "recall_number": "D-0313-2023", "classification": "Class II", "recalling_firm": "Sentara Infusion Services", "product_quantity": "14 bags", "termination_date": "20260220", "reason_for_recall": "Lack of sterility assurance", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320", "distribution_pattern": "Dispensed to Patients Nationwide.", "recall_initiation_date": "20221227", "initial_firm_notification": "Telephone", "center_classification_date": "20230215"} 2026-07-08 15:18:29.552238-07
+mrcl_01kx1wz9prd6005xg1xxp66vgp user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-653-2014 Class II Terminated Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014; HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014; MELATONIN, Tablet, 3 mg, NDC VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-653-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet has the following codes Pedigree: AD73652_19, EXP: 5/30/2014; Pedigree: W003591, EXP: 6/24/2014; Pedigree: AD70655_17, EXP: 5/28/2014; Pedigree: W003361, EXP: 6/19/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-653-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "600 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014; HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014; MELATONIN, Tablet, 3 mg, NDC", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:29.97687-07
+mrcl_01kx1wz9psba11rf2m7r1ydyns user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-0270-2017 Class II Ongoing Lack of Assurance of Sterility Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy 2016-11-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2017 {"city": "Juno Beach", "state": "FL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "75763", "address_1": "14125 US Highway 1", "address_2": "N/A", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 09022016A (12/31/2016), 07282016C (12/31/2016)", "postal_code": "33408-1425", "report_date": "20170111", "product_type": "Drugs", "recall_number": "D-0270-2017", "classification": "Class II", "recalling_firm": "Tri-Coast Pharmacy", "product_quantity": "987 vials", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy", "distribution_pattern": "Nationwide", "recall_initiation_date": "20161117", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20170104"} 2026-07-08 15:18:29.977643-07
+mrcl_01kx1wz9ptwq7011rz0p3gerfg user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-0322-2017 Class II Ongoing Lack of Assurance of Sterility Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Arginine HCL 200mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy 2016-11-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0322-2017 {"city": "Juno Beach", "state": "FL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "75763", "address_1": "14125 US Highway 1", "address_2": "N/A", "code_info": "Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016B (11/19/2016), 07272016C (11/30/2016), 07152016H (11/30/2016), 09152016B (12/31/2016), 11022016B (05/01/2017), 06082016B (11/30/2016), 08172016C (12/31/2016), 10202016C (02/28/2017).", "postal_code": "33408-1425", "report_date": "20170111", "product_type": "Drugs", "recall_number": "D-0322-2017", "classification": "Class II", "recalling_firm": "Tri-Coast Pharmacy", "product_quantity": "870 vials", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Arginine HCL 200mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy", "distribution_pattern": "Nationwide", "recall_initiation_date": "20161117", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20170104"} 2026-07-08 15:18:29.978454-07
+mrcl_01kx1wza2ym4vvgybvhc2xjepj user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-138-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. 2012-12-06 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-138-2013 {"city": "Huntsville", "state": "AL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63818", "address_1": "120 Vintage Dr NE", "address_2": "", "code_info": "Lot #: All that begin with the letter \\"C\\" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20130206", "product_type": "Drugs", "recall_number": "D-138-2013", "classification": "Class I", "more_code_info": "", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "897,379 bottles", "termination_date": "20210720", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20121206", "initial_firm_notification": "Press Release", "center_classification_date": "20130130"} 2026-07-08 15:18:30.366287-07
+mrcl_01kx1wz9pv4zf39vdpw8w927ad user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-0481-2019 Class II Terminated Lack of sterility assurance. Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 2018-12-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0481-2019 {"city": "Palm Harbor", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "81810", "address_1": "31818 Us Highway 19 N", "address_2": "N/A", "code_info": "Lot: 10302018@8, BUD 12/14/2018", "postal_code": "34684-3713", "report_date": "20190220", "product_type": "Drugs", "recall_number": "D-0481-2019", "classification": "Class II", "recalling_firm": "Promise Pharmacy, LLC", "product_quantity": "1 10 ml vial", "termination_date": "20210330", "reason_for_recall": "Lack of sterility assurance.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "distribution_pattern": "Nationwide in the USA.", "recall_initiation_date": "20181217", "initial_firm_notification": "Letter", "center_classification_date": "20190208"} 2026-07-08 15:18:29.979514-07
+mrcl_01kx1wz9pv29ceet72r4gn6p7b user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-1202-2022 Class II Ongoing Lack of Assurance of Sterility Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding 2022-03-07 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1202-2022 {"city": "Nicholasville", "state": "KY", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "89909", "address_1": "200 Moore Dr", "address_2": "", "code_info": "Batch#: 10132102A2, Exp 3/22/2022; 01062221B, Exp 4/30/2022; 11302103A1, Exp 4/30/2022; 03032227A1, Exp 8/29/2022.", "postal_code": "40356-8512", "report_date": "20220720", "product_type": "Drugs", "recall_number": "D-1202-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "TMC Acquisition LLC dba Tailor Made Compounding", "product_quantity": "45", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding", "distribution_pattern": "Nationwide USA and Puerto Rico", "recall_initiation_date": "20220307", "initial_firm_notification": "Letter", "center_classification_date": "20220714"} 2026-07-08 15:18:29.979915-07
+mrcl_01kx1wz9pw7payxh0bqzha3qmj user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-0371-2016 Class II Terminated Lack of Assurance of Sterility Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 2015-10-16 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0371-2016 {"city": "Dallas", "state": "TX", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "72455", "address_1": "4001 McEwen Rd Suite 110", "address_2": "N/A", "code_info": "All lots", "postal_code": "75244-5020", "report_date": "20151125", "product_type": "Drugs", "recall_number": "D-0371-2016", "classification": "Class II", "recalling_firm": "Downing Labs, LLC", "product_quantity": "178 vials", "termination_date": "20160922", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435", "distribution_pattern": "Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan", "recall_initiation_date": "20151016", "initial_firm_notification": "Press Release", "center_classification_date": "20151118"} 2026-07-08 15:18:29.980245-07
+mrcl_01kx1wz9pwxgkjpqypbr49h2hf user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-0472-2019 Class II Terminated Lack of sterility assurance. Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 2018-12-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2019 {"city": "Palm Harbor", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "81810", "address_1": "31818 Us Highway 19 N", "address_2": "N/A", "code_info": "Lots: 11022018@4 BUD: 12/17/2018;", "postal_code": "34684-3713", "report_date": "20190220", "product_type": "Drugs", "recall_number": "D-0472-2019", "classification": "Class II", "recalling_firm": "Promise Pharmacy, LLC", "product_quantity": "5 10ml vials", "termination_date": "20210330", "reason_for_recall": "Lack of sterility assurance.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684", "distribution_pattern": "Nationwide in the USA.", "recall_initiation_date": "20181217", "initial_firm_notification": "Letter", "center_classification_date": "20190208"} 2026-07-08 15:18:29.980636-07
+mrcl_01kx1wz9pw5nnmmdwd77ec2az0 user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-1502-2015 Class II Terminated Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN 2015-06-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1502-2015 {"city": "Knoxville", "state": "TN", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "71371", "address_1": "6216 Highland Place Way Ste 101-A", "address_2": "", "code_info": "All lots distributed between November 2014 and May 2015; 04222015@69, 7/21/2015", "postal_code": "37919-4068", "report_date": "20150923", "product_type": "Drugs", "recall_number": "D-1502-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "The Compounding Pharmacy of America", "product_quantity": "33 ml total volume", "termination_date": "20160210", "reason_for_recall": "Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150602", "initial_firm_notification": "Telephone", "center_classification_date": "20150915"} 2026-07-08 15:18:29.981004-07
+mrcl_01kx1wzaf76yw6age4z0155ry4 user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-0435-2021 Class II Terminated CGMP Deviations: Intermittent exposure to temperature excursion during storage. xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791 2021-03-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2021 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {"unii": ["786Z46389E", "887K2391VH"], "route": ["ORAL"], "rxcui": ["1593058", "1593068", "1593070", "1593072", "1593775", "1593831", "1593833", "1593835", "1940496", "1940498"], "spl_id": ["a8717b28-9445-4292-9ac7-e979f378d9c8"], "brand_name": ["XIGDUO"], "spl_set_id": ["ac8a0f7b-9f69-4495-abbc-3a47cd75a859"], "package_ndc": ["0310-6270-30", "0310-6270-95", "0310-6280-30", "0310-6280-95", "0310-6250-30", "0310-6250-95", "0310-6260-30", "0310-6260-60", "0310-6260-94", "0310-6260-95", "0310-6225-60", "0310-6225-94"], "product_ndc": ["0310-6225", "0310-6270", "0310-6280", "0310-6250", "0310-6260"], "generic_name": ["DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["DAPAGLIFLOZIN PROPANEDIOL", "METFORMIN HYDROCHLORIDE"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "application_number": ["NDA205649"], "is_original_packager": [true]}, "event_id": "87512", "address_1": "7000 Cardinal Pl", "address_2": "N/A", "code_info": "MP0077", "postal_code": "43017-1091", "report_date": "20210602", "product_type": "Drugs", "recall_number": "D-0435-2021", "classification": "Class II", "recalling_firm": "Cardinal Health Inc.", "product_quantity": "664 bottles", "termination_date": "20240617", "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791", "distribution_pattern": "FL, GA, SC", "recall_initiation_date": "20210315", "initial_firm_notification": "Letter", "center_classification_date": "20210524"} 2026-07-08 15:18:30.759901-07
+mrcl_01kx1wz9pxb27tqjys3vmpg05a user_steve med_01kx1wz68pab2mxy6jqpy7t2y7 openFDA D-0801-2016 Class III Terminated Defective Delivery System: Product may contain leaking capsules. VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305 2015-12-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0801-2016 {"city": "Tampa", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "73295", "address_1": "2649 Causeway Center Dr", "address_2": "N/A", "code_info": "Lot #21506132; Exp. 05/17", "postal_code": "33619-6102", "report_date": "20160413", "product_type": "Drugs", "recall_number": "D-0801-2016", "classification": "Class III", "more_code_info": "", "recalling_firm": "Virtus Pharmaceuticals, Llc", "product_quantity": "688 bottles ( 20,640 softgel capsules)", "termination_date": "20180816", "reason_for_recall": "Defective Delivery System: Product may contain leaking capsules.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305", "distribution_pattern": "Nationwide", "recall_initiation_date": "20151217", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20160401"} 2026-07-08 15:18:29.981328-07
+mrcl_01kx1wza2vjxz8txh2vjdjqz31 user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-058-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. 2012-09-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-058-2013 {"city": "Corona", "state": "CA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63246", "address_1": "311 Bonnie Cir", "address_2": "N/A", "code_info": "Lot #: 519406A, 521759A, Exp 04/14", "postal_code": "92880-2882", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-058-2013", "classification": "Class I", "recalling_firm": "Watson Laboratories Inc", "product_quantity": "4,874 bottles", "termination_date": "20140324", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20120921", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:30.363986-07
+mrcl_01kx1wza2wq4m2temcpa96ezkh user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-0599-2018 Class III Terminated Failed Impurities/Degradation Specifications Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038 2018-03-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2018 {"city": "Somerset", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0343386118038", "343386118038"], "unii": ["68JRS2HC1C", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["992656"], "spl_id": ["116df522-26b7-42de-8c0b-16cc60c2e764"], "brand_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "spl_set_id": ["41ac90b3-f007-4eb2-9d41-ea626ced2017"], "package_ndc": ["43386-118-03", "43386-118-01", "43386-118-05", "3433861180"], "product_ndc": ["43386-118"], "generic_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["HOMATROPINE METHYLBROMIDE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "application_number": ["ANDA091528"], "is_original_packager": [true]}, "event_id": "79298", "address_1": "400 Campus Dr", "address_2": "", "code_info": "M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);", "postal_code": "08873-1145", "report_date": "20180321", "product_type": "Drugs", "recall_number": "D-0599-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Novel Laboratories, Inc.", "product_quantity": "134,364 bottles (4,030,920 tablets)", "termination_date": "20200608", "reason_for_recall": "Failed Impurities/Degradation Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038", "distribution_pattern": "Nationwide", "recall_initiation_date": "20180305", "initial_firm_notification": "Letter", "center_classification_date": "20180314"} 2026-07-08 15:18:30.364835-07
+mrcl_01kx1wza2x4b8tpaavay1q88nm user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-0276-2022 Class II Terminated Product Mix-up Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01. 2021-11-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2022 {"city": "Central Islip", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0331722997010", "0331722996013"], "unii": ["362O9ITL9D", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["856999", "857002"], "spl_id": ["d745e0ac-ee48-44c7-8430-8da0a69d2735"], "brand_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "spl_set_id": ["ed6af366-753c-4f3b-a6a2-c9a183c50035"], "package_ndc": ["31722-996-01", "31722-996-05", "31722-997-01", "31722-997-05"], "product_ndc": ["31722-996", "31722-997"], "generic_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ACETAMINOPHEN", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "application_number": ["ANDA211487"], "is_original_packager": [true]}, "event_id": "89060", "address_1": "400 S Technology Dr", "address_2": "N/A", "code_info": "Lot #: 21070817, Exp 6/2023", "postal_code": "11722-4402", "report_date": "20211215", "product_type": "Drugs", "recall_number": "D-0276-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Ascent Pharmaceuticals, Inc.", "product_quantity": "9744 bottles", "termination_date": "20231206", "reason_for_recall": "Product Mix-up", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20211119", "initial_firm_notification": "Letter", "center_classification_date": "20211207"} 2026-07-08 15:18:30.365535-07
+mrcl_01kx1wza2xb7m121awpvht41r4 user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-1383-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1383-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18B013, Exp. 02/2020; 18E024; 18E030, Exp. 05/2020.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1383-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "11,112 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:30.365977-07
+mrcl_01kx1wzaf8w4cyjmtnjpsknmrb user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-0325-2021 Class III Terminated Failed Moisture Limits: Out of specification for water content Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02. 2021-03-25 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0325-2021 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0362756142015", "0362756143012"], "unii": ["786Z46389E"], "route": ["ORAL"], "spl_id": ["5513972d-0ee6-c934-e063-6394a90a2f52"], "brand_name": ["METFORMIN HYDROCHLORIDE"], "spl_set_id": ["41a8bb80-7b0b-476c-8134-5d161c3239c8"], "package_ndc": ["62756-142-01", "62756-142-02", "62756-143-01"], "product_ndc": ["62756-142", "62756-143"], "generic_name": ["METFORMIN HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METFORMIN HYDROCHLORIDE"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "application_number": ["ANDA077336"], "is_original_packager": [true]}, "event_id": "87617", "address_1": "2 Independence Way", "address_2": "N/A", "code_info": "Lot #JKU4639A, Exp 10/2022", "postal_code": "08540-6620", "report_date": "20210414", "product_type": "Drugs", "recall_number": "D-0325-2021", "classification": "Class III", "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "product_quantity": "2520 bottles", "termination_date": "20220414", "reason_for_recall": "Failed Moisture Limits: Out of specification for water content", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20210325", "initial_firm_notification": "Letter", "center_classification_date": "20210407"} 2026-07-08 15:18:30.760544-07
+mrcl_01kx1wza2yqve693zrzn0v2e3a user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-1384-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1384-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1384-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "7,728 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:30.366988-07
+mrcl_01kx1wza2z8sj5dv2b2wgn3ccj user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-057-2013 Class I Ongoing Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 2012-09-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-057-2013 {"city": "Huntsville", "state": "AL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "63138", "address_1": "120 Vintage Dr NE", "address_2": "N/A", "code_info": "Lot number: C1440512A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-057-2013", "classification": "Class I", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "14,445 bottles", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21", "distribution_pattern": "Nationwide.", "recall_initiation_date": "20120910", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:30.36751-07
+mrcl_01kx1wza308zhg3mjr399arf08 user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-1517-2019 Class II Terminated Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. 2019-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2019 {"city": "Monmouth Junction", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0327808086013"], "unii": ["V1Q0O9OJ9Z", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["1087459"], "spl_id": ["b3ac95d4-bef9-4e32-9822-73b9534c9869"], "brand_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "spl_set_id": ["25f400d9-1d6e-4d38-8f0d-98d471eba73b"], "package_ndc": ["27808-086-02", "27808-086-01", "27808-086-03"], "product_ndc": ["27808-086"], "generic_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["CHLORPHENIRAMINE MALEATE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "application_number": ["ANDA091632"], "is_original_packager": [true]}, "event_id": "83346", "address_1": "2033 US Highway 130", "address_2": "N/A", "code_info": "Lot#: 14079, Exp 10/2021", "postal_code": "08852-3003", "report_date": "20190731", "product_type": "Drugs", "recall_number": "D-1517-2019", "classification": "Class II", "recalling_firm": "Tris Pharma Inc.", "product_quantity": "2,550 bottles", "termination_date": "20211102", "reason_for_recall": "Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20190711", "initial_firm_notification": "Letter", "center_classification_date": "20190724"} 2026-07-08 15:18:30.368967-07
+mrcl_01kx1wza31f1r22q95k8exep8k user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-609-2014 Class II Terminated Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014. HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-609-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg has the following code Pedigree: W004005, EXP: 7/1/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-609-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:30.369445-07
+mrcl_01kx1wza31qamaegftawbc17wn user_steve med_01kx1wz68pqdmfb7z466j89f9d openFDA D-1139-2017 Class III Terminated Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16 2017-08-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2017 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77998", "address_1": "7265 Ulmerton Rd", "address_2": "N/A", "code_info": "Lot: 494700 Exp. 10/2018", "postal_code": "33771-4809", "report_date": "20170920", "product_type": "Drugs", "recall_number": "D-1139-2017", "classification": "Class III", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "3084 bottles", "termination_date": "20190311", "reason_for_recall": "Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16", "distribution_pattern": "Nationwide", "recall_initiation_date": "20170817", "initial_firm_notification": "Letter", "center_classification_date": "20170912"} 2026-07-08 15:18:30.369838-07
+mrcl_01kx1wzaf95fwv08bnqws09rbv user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-1331-2020 Class II Terminated CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 2020-06-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1331-2020 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "85797", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "a) 1329548A, exp. date 06/2020 1338302M, exp. date 10/2020 1348968M, exp. date 10/2020 1348969M, exp. date 10/2020 1348970M, exp. date 11/2020 1376339M,, exp. date 09/2021 b) 1323460M, exp. date 06/2020 1330919M, exp. date 6/2020 1338300A, exp. date 10/2020 1341135M, exp. date 12/2020 1391828M, exp. date 11/2021", "postal_code": "07054-1120", "report_date": "20200701", "product_type": "Drugs", "recall_number": "D-1331-2020", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "a) 92,793 bottles and b) 4,824 bottles", "termination_date": "20240412", "reason_for_recall": "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ", "distribution_pattern": "Product was distributed throughout the United States, including Puerto Rico.", "recall_initiation_date": "20200602", "initial_firm_notification": "Press Release", "center_classification_date": "20200619"} 2026-07-08 15:18:30.761412-07
+mrcl_01kx1wzafafe4vwp0nn6xabgh2 user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-0292-2025 Class II Ongoing Presence of Foreign Tablets/Capsules. METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. 2025-02-25 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2025 {"city": "Libertyville", "state": "IL", "status": "Ongoing", "country": "United States", "openfda": {"unii": ["786Z46389E"], "route": ["ORAL"], "rxcui": ["860975"], "spl_id": ["c83706bb-e844-4e62-b4f4-c48536ea707d"], "brand_name": ["METFORMIN HYDROCHLORIDE"], "spl_set_id": ["0cd086d6-3ae2-476e-b93e-29055e67e8fc"], "package_ndc": ["50090-1494-3", "50090-1494-4", "50090-1494-0", "50090-1494-1", "50090-1494-2"], "product_ndc": ["50090-1494"], "generic_name": ["METFORMIN HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METFORMIN HYDROCHLORIDE"], "manufacturer_name": ["A-S Medication Solutions"], "application_number": ["ANDA201991"], "original_packager_product_ndc": ["67877-159"]}, "event_id": "96313", "address_1": "2401 Commerce Dr", "address_2": "N/A", "code_info": "Lot# 4260340; Exp.12/31/2025.", "postal_code": "60048-4464", "report_date": "20250402", "product_type": "Drugs", "recall_number": "D-0292-2025", "classification": "Class II", "recalling_firm": "A-S Medication Solutions LLC", "product_quantity": "411 180-count bottles", "reason_for_recall": "Presence of Foreign Tablets/Capsules.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.", "distribution_pattern": "Nationwide in U.S.", "recall_initiation_date": "20250225", "initial_firm_notification": "Letter", "center_classification_date": "20250321"} 2026-07-08 15:18:30.762225-07
+mrcl_01kx1wzafa0q3087v8pgdjpvak user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-1448-2014 Class I Terminated Labeling: Label Mix up; product labeled did not indicated Extended Release metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01 2011-09-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1448-2014 {"city": "Lewis Center", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "64611", "address_1": "741 Radio Dr", "address_2": "", "code_info": "Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01", "postal_code": "43035-7134", "report_date": "20140730", "product_type": "Drugs", "recall_number": "D-1448-2014", "classification": "Class I", "more_code_info": "", "recalling_firm": "Shamrock Medical Solutions Group LLC", "product_quantity": "88/5 mg tablets", "termination_date": "20140731", "reason_for_recall": "Labeling: Label Mix up; product labeled did not indicated Extended Release", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01", "distribution_pattern": "Product was shipped to the following states: CO, MA, OH, TX & WY.", "recall_initiation_date": "20110927", "initial_firm_notification": "Telephone", "center_classification_date": "20140723"} 2026-07-08 15:18:30.762641-07
+mrcl_01kx1wzafasp32bpwaxs6k53rg user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-0026-2019 Class II Terminated Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets. Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30 2018-09-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0026-2019 {"city": "Deerfield", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "80964", "address_1": "1 Takeda Pkwy", "address_2": "4034BB1", "code_info": "Lot, expiry: A26004, exp Apr 2020; A26443 and A26444, exp Sep 2020", "postal_code": "60015-5713", "report_date": "20181017", "product_type": "Drugs", "recall_number": "D-0026-2019", "classification": "Class II", "more_code_info": "", "recalling_firm": "Takeda Development Center Americas, Inc.", "product_quantity": "7,248 bottles", "termination_date": "20200413", "reason_for_recall": "Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30", "distribution_pattern": "AR, LA, MS, NC, NJ, OH, PA, SC and Puerto Rico", "recall_initiation_date": "20180910", "initial_firm_notification": "Letter", "center_classification_date": "20181015"} 2026-07-08 15:18:30.763042-07
+mrcl_01kx1wzafbxr4egwrzjtzk0zft user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-1356-2020 Class II Terminated CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01 2020-06-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1356-2020 {"city": "Vasco Da Gama", "state": "N/A", "status": "Terminated", "country": "India", "openfda": {"upc": ["0349483624014", "0349483623109", "0349483623017"], "unii": ["786Z46389E"], "route": ["ORAL"], "rxcui": ["860975", "860981"], "spl_id": ["4d845f5a-3ab1-b5ac-e063-6394a90a75d6"], "brand_name": ["METFORMIN HYDROCHLORIDE EXTENDED RELEASE"], "spl_set_id": ["1d8b8970-c2a1-4780-be87-ab8ccfd401fa"], "package_ndc": ["49483-623-09", "49483-623-01", "49483-623-50", "49483-623-10", "49483-624-01", "49483-624-50"], "product_ndc": ["49483-623", "49483-624"], "generic_name": ["METFORMIN HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METFORMIN HYDROCHLORIDE"], "manufacturer_name": ["TIME CAP LABORATORIES, INC"], "application_number": ["ANDA090295"], "is_original_packager": [true]}, "event_id": "85818", "address_1": "& L - 83 Plots L - 82", "address_2": "Verna, Goa", "code_info": "XP9004, exp 12/2020", "postal_code": "N/A", "report_date": "20200701", "product_type": "Drugs", "recall_number": "D-1356-2020", "classification": "Class II", "recalling_firm": "Marksans Pharma Limited", "product_quantity": "11279 bottles", "termination_date": "20230907", "reason_for_recall": "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01", "distribution_pattern": "Nationwide", "recall_initiation_date": "20200605", "initial_firm_notification": "Press Release", "center_classification_date": "20200625"} 2026-07-08 15:18:30.763467-07
+mrcl_01kx1wzc0kgvysjakm56pkjpgv user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-0123-2024 Class II Ongoing Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01 2023-11-07 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0123-2024 {"city": "Mahwah", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368462406014", "0368462302019"], "unii": ["XXE1CET956"], "route": ["ORAL"], "rxcui": ["197817", "197818"], "spl_id": ["bcf62935-0bd5-479f-9680-c5b4eba5a529"], "brand_name": ["INDOMETHACIN"], "spl_set_id": ["f7ed39e2-5431-4e47-935c-c7441d058f94"], "package_ndc": ["68462-406-01", "68462-406-10", "68462-302-01", "68462-302-05"], "product_ndc": ["68462-302", "68462-406"], "generic_name": ["INDOMETHACIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["INDOMETHACIN"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA091276"], "is_original_packager": [true]}, "event_id": "93368", "address_1": "750 Corporate Dr", "address_2": "", "code_info": "Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484; Exp 8/2025 Lot# 19233490; Exp 8/2025", "postal_code": "07430-2009", "report_date": "20231206", "product_type": "Drugs", "recall_number": "D-0123-2024", "classification": "Class II", "more_code_info": "", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "product_quantity": "37,200 bottles", "reason_for_recall": "Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01", "distribution_pattern": "Nationwide", "recall_initiation_date": "20231107", "initial_firm_notification": "Letter", "center_classification_date": "20231127"} 2026-07-08 15:18:32.33931-07
+mrcl_01kx1wzafchamzf90txe3dw51s user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-019-2013 Class II Terminated Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly. Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850. 2012-06-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-019-2013 {"city": "New Brunswick", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "62898", "address_1": "1 Squibb Dr", "address_2": "N/A", "code_info": "Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13", "postal_code": "08901", "report_date": "20121031", "product_type": "Drugs", "recall_number": "D-019-2013", "classification": "Class II", "recalling_firm": "Bristol-myers Squibb Company", "product_quantity": "N/A", "termination_date": "20130710", "reason_for_recall": "Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20120605", "initial_firm_notification": "Letter", "center_classification_date": "20121024"} 2026-07-08 15:18:30.764523-07
+mrcl_01kx1wzafd4zabr5mq3qn7gx4h user_steve med_01kx1wz68pfzwxa0x9hbcw6fe4 openFDA D-0061-2021 Class II Terminated CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50 2020-10-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0061-2021 {"city": "Vasco Da Gama", "state": "N/A", "status": "Terminated", "country": "India", "openfda": {"upc": ["0349483624014", "0349483623109", "0349483623017"], "unii": ["786Z46389E"], "route": ["ORAL"], "rxcui": ["860975", "860981"], "spl_id": ["4d845f5a-3ab1-b5ac-e063-6394a90a75d6"], "brand_name": ["METFORMIN HYDROCHLORIDE EXTENDED RELEASE"], "spl_set_id": ["1d8b8970-c2a1-4780-be87-ab8ccfd401fa"], "package_ndc": ["49483-623-09", "49483-623-01", "49483-623-50", "49483-623-10", "49483-624-01", "49483-624-50"], "product_ndc": ["49483-623", "49483-624"], "generic_name": ["METFORMIN HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METFORMIN HYDROCHLORIDE"], "manufacturer_name": ["TIME CAP LABORATORIES, INC"], "application_number": ["ANDA090295"], "is_original_packager": [true]}, "event_id": "86530", "address_1": "& L - 83 Plots L - 82", "address_2": "Verna, Goa", "code_info": "a) 90 count: E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20; L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013 Mar-22; A40015 Apr-22 b) 100 count: XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22; c) 500 count: E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22; d) 1000 count: D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 Apr-22", "postal_code": "N/A", "report_date": "20201111", "product_type": "Drugs", "recall_number": "D-0061-2021", "classification": "Class II", "recalling_firm": "Marksans Pharma Limited", "product_quantity": "a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles", "termination_date": "20240221", "reason_for_recall": "CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50", "distribution_pattern": "Nationwide", "recall_initiation_date": "20201002", "initial_firm_notification": "Press Release", "center_classification_date": "20201102"} 2026-07-08 15:18:30.765305-07
+mrcl_01kx1wzawfbb625htwpcjgkcyq user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-1191-2018 Class II Terminated Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153 2018-09-04 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1191-2018 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0355111180104", "0355111179108"], "unii": ["B53E3NMY5C"], "route": ["ORAL"], "rxcui": ["313412", "313413"], "spl_id": ["386ec98d-4a47-b025-b050-7e4ebce382c6"], "brand_name": ["TIZANIDINE"], "spl_set_id": ["a42f3479-f2c2-8214-d547-c5cae9bfed1e"], "package_ndc": ["55111-179-30", "55111-179-15", "55111-179-03", "55111-179-10", "55111-180-30", "55111-180-15", "55111-180-03", "55111-180-10", "3551117915"], "product_ndc": ["55111-179", "55111-180"], "generic_name": ["TIZANIDINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["TIZANIDINE HYDROCHLORIDE"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "application_number": ["ANDA076286"], "is_original_packager": [true]}, "event_id": "80953", "address_1": "107 College Rd E", "address_2": "N/A", "code_info": "Lot #: T800304, Exp. 03/2021", "postal_code": "08540-6623", "report_date": "20180926", "product_type": "Drugs", "recall_number": "D-1191-2018", "classification": "Class II", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "8376 units", "termination_date": "20220301", "reason_for_recall": "Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153", "distribution_pattern": "Nationwide within the United States", "recall_initiation_date": "20180904", "initial_firm_notification": "Letter", "center_classification_date": "20180917"} 2026-07-08 15:18:31.18397-07
+mrcl_01kx1wzawg6a3egynarwdrwcdq user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-1427-2012 Class III Terminated Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label. Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90. 2012-07-23 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1427-2012 {"city": "Gainesville", "state": "GA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "62639", "address_1": "2481 Hilton Dr", "address_2": "", "code_info": "Lot #: 28JN1272, Exp 02/15", "postal_code": "30501-6213", "report_date": "20120801", "product_type": "Drugs", "recall_number": "D-1427-2012", "classification": "Class III", "more_code_info": "", "recalling_firm": "Stat Rx USA", "product_quantity": "51 Bottles", "termination_date": "20130131", "reason_for_recall": "Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20120723", "initial_firm_notification": "E-Mail", "center_classification_date": "20120726"} 2026-07-08 15:18:31.184901-07
+mrcl_01kx1wzawh1s7bvdqm4jzegnzq user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-0750-2021 Class II Terminated Failed Tablet/Capsule Specification: Some tablets are shaved Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15. 2021-07-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0750-2021 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0355111180104", "0355111179108"], "unii": ["B53E3NMY5C"], "route": ["ORAL"], "rxcui": ["313412", "313413"], "spl_id": ["386ec98d-4a47-b025-b050-7e4ebce382c6"], "brand_name": ["TIZANIDINE"], "spl_set_id": ["a42f3479-f2c2-8214-d547-c5cae9bfed1e"], "package_ndc": ["55111-179-30", "55111-179-15", "55111-179-03", "55111-179-10", "55111-180-30", "55111-180-15", "55111-180-03", "55111-180-10"], "product_ndc": ["55111-179", "55111-180"], "generic_name": ["TIZANIDINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["TIZANIDINE HYDROCHLORIDE"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "application_number": ["ANDA076286"], "is_original_packager": [true]}, "event_id": "88309", "address_1": "107 College Rd E", "address_2": "N/A", "code_info": "Lot #: T2000471, exp date 09/2023", "postal_code": "08540-6623", "report_date": "20210825", "product_type": "Drugs", "recall_number": "D-0750-2021", "classification": "Class II", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "37560 bottles", "termination_date": "20221221", "reason_for_recall": "Failed Tablet/Capsule Specification: Some tablets are shaved", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.", "distribution_pattern": "Nationwide within the United States", "recall_initiation_date": "20210719", "initial_firm_notification": "Letter", "center_classification_date": "20210818"} 2026-07-08 15:18:31.185403-07
+mrcl_01kx1wzawj7nq4hyk5gjry8ew5 user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-931-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Tizanidine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-931-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-931-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "700 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Tizanidine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:31.186356-07
+mrcl_01kx1wzawjy416r8jphte3d1kd user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-620-2014 Class II Terminated Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014. tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-620-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "tiZANidine HCl, Tablet, 1 mg (1/2 of 2 mg) has the following code Pedigree: AD60272_52, EXP: 5/22/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-620-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "299 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD60428_10, EXP: 5/22/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:31.187053-07
+mrcl_01kx1wzawmw14z8edg7g2td9jm user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-893-2014 Class II Terminated Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC 00904434260, Pedigree: W002969, EXP: 6/11/2014. tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378072219. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-893-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "tiZANidine HCl, Tablet, 2 mg has the following codes: Pedigree: W002975, EXP: 6/11/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-893-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "150 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC 00904434260, Pedigree: W002969, EXP: 6/11/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378072219.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:31.188434-07
+mrcl_01kx1wzawm24v2s4hrqmqg5aae user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-238-2013 Class III Terminated Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15. 2013-03-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-238-2013 {"city": "Bridgewater", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0355111180104", "0355111179108"], "unii": ["B53E3NMY5C"], "route": ["ORAL"], "rxcui": ["313412", "313413"], "spl_id": ["386ec98d-4a47-b025-b050-7e4ebce382c6"], "brand_name": ["TIZANIDINE"], "spl_set_id": ["a42f3479-f2c2-8214-d547-c5cae9bfed1e"], "package_ndc": ["55111-179-30", "55111-179-15", "55111-179-03", "55111-179-10", "55111-180-30", "55111-180-15", "55111-180-03", "55111-180-10"], "product_ndc": ["55111-179", "55111-180"], "generic_name": ["TIZANIDINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["TIZANIDINE HYDROCHLORIDE"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "application_number": ["ANDA076286"], "is_original_packager": [true]}, "event_id": "64733", "address_1": "200 Somerset Corporate Blvd FL 7", "address_2": "Blvd 11 7th Floor", "code_info": "Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.", "postal_code": "08807-2862", "report_date": "20130410", "product_type": "Drugs", "recall_number": "D-238-2013", "classification": "Class III", "recalling_firm": "Dr. Reddy'S Laboratories", "product_quantity": "117,546 bottles", "termination_date": "20140206", "reason_for_recall": "Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.", "distribution_pattern": "Nationwide and Puerto Rico.", "recall_initiation_date": "20130319", "initial_firm_notification": "Letter", "center_classification_date": "20130401"} 2026-07-08 15:18:31.188976-07
+mrcl_01kx1wzawnrfyrx3y8awbh7k9k user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-0173-2021 Class II Terminated Failed Dissolution Specifications; Out of Specification (low) results were obtained. Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15. 2020-11-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"unii": ["B53E3NMY5C"], "route": ["ORAL"], "rxcui": ["313412", "313413"], "spl_id": ["e9f19258-b62c-471d-82c4-1e2bdc030833"], "brand_name": ["TIZANIDINE"], "spl_set_id": ["72f25135-1333-4e52-83f5-7df7d90e68bb"], "package_ndc": ["67877-613-15", "67877-613-05", "67877-614-15", "67877-614-05"], "product_ndc": ["67877-613", "67877-614"], "generic_name": ["TIZANIDINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["TIZANIDINE HYDROCHLORIDE"], "manufacturer_name": ["Ascend Laboratories, LLC"], "application_number": ["ANDA211798"], "is_original_packager": [true]}, "event_id": "86859", "address_1": "339 Jefferson Rd Ste 101", "address_2": "N/A", "code_info": "Lot #19143017, Exp. 05/31/2021", "postal_code": "07054-3707", "report_date": "20201209", "product_type": "Drugs", "recall_number": "D-0173-2021", "classification": "Class II", "more_code_info": "", "recalling_firm": "Ascend Laboratories LLC", "product_quantity": "1200 bottles", "termination_date": "20230411", "reason_for_recall": "Failed Dissolution Specifications; Out of Specification (low) results were obtained.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.", "distribution_pattern": "MI", "recall_initiation_date": "20201124", "initial_firm_notification": "E-Mail", "center_classification_date": "20201222"} 2026-07-08 15:18:31.189791-07
+mrcl_01kx1wzawpse7yeyrerhyvk6zm user_steve med_01kx1wz68qp885wznasv6d3vck openFDA D-0894-2023 Class II Ongoing Failed Stability Specifications Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited. 2023-06-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0894-2023 {"city": "Anaheim", "state": "CA", "status": "Ongoing", "country": "United States", "openfda": {"unii": ["B53E3NMY5C"], "route": ["ORAL"], "rxcui": ["313413"], "spl_id": ["c2ed0d31-f724-4410-85b9-eb03eb7ab9bc"], "brand_name": ["TIZANIDINE"], "spl_set_id": ["32c3be66-5398-425c-ac65-e57ba819bb43"], "package_ndc": ["68788-7781-2", "68788-7781-3", "68788-7781-6", "68788-7781-9", "68788-7781-1", "68788-7781-8"], "product_ndc": ["68788-7781"], "generic_name": ["TIZANIDINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["TIZANIDINE HYDROCHLORIDE"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."], "application_number": ["ANDA076286"], "original_packager_product_ndc": ["55111-180"]}, "event_id": "92625", "address_1": "1250 N Lakeview Ave Ste O", "address_2": "N/A", "code_info": "Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023", "postal_code": "92807-1801", "report_date": "20230712", "product_type": "Drugs", "recall_number": "D-0894-2023", "classification": "Class II", "recalling_firm": "Preferred Pharmaceuticals, Inc.", "product_quantity": "541 Bottles", "reason_for_recall": "Failed Stability Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.", "distribution_pattern": "Nationwide within the United States", "recall_initiation_date": "20230626", "initial_firm_notification": "Letter", "center_classification_date": "20230705"} 2026-07-08 15:18:31.190378-07
+mrcl_01kx1wzb88az3n6ckr6jxb4m9z user_steve med_01kx1wz68qy90y5epx0n25yx35 openFDA D-0459-2025 Class II Ongoing Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71 2025-05-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0459-2025 {"city": "Panchmahal", "state": "", "status": "Ongoing", "country": "India", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0362332142309", "0362332143306", "0362332141302", "0362332140305"], "unii": ["JCX84Q7J1L"], "route": ["ORAL"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_id": ["0ae26abe-bbc0-48bf-b038-ca400ee197cd"], "brand_name": ["CELECOXIB"], "spl_set_id": ["806e5f8a-f986-4f88-ba3e-8265f86afa48"], "package_ndc": ["62332-140-30", "62332-140-60", "62332-140-91", "62332-140-08", "62332-141-30", "62332-141-31", "62332-141-91", "62332-141-08", "62332-141-60", "62332-141-71", "62332-142-30", "62332-142-31", "62332-142-91", "62332-142-71", "62332-142-08", "62332-142-60", "62332-143-30", "62332-143-60", "62332-143-71", "62332-143-10", "2405014780"], "product_ndc": ["62332-140", "62332-141", "62332-142", "62332-143"], "generic_name": ["CELECOXIB"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["CELECOXIB"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "application_number": ["ANDA204519"], "is_original_packager": [true]}, "event_id": "96840", "address_1": "Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol", "address_2": "", "code_info": "Batch 2405014780, Exp. Date: Sep. 30, 2027", "postal_code": "N/A", "report_date": "20250618", "product_type": "Drugs", "recall_number": "D-0459-2025", "classification": "Class II", "more_code_info": "", "recalling_firm": "Alembic Pharmaceuticals Limited", "product_quantity": "2,946 500-count bottles", "reason_for_recall": "Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71", "distribution_pattern": "Distributed Nationwide and in PR", "recall_initiation_date": "20250509", "initial_firm_notification": "Letter", "center_classification_date": "20250606"} 2026-07-08 15:18:31.560997-07
+mrcl_01kx1wzb8aajp4xj48thy7bqxj user_steve med_01kx1wz68qy90y5epx0n25yx35 openFDA D-0460-2025 Class II Ongoing Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15 2025-05-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0460-2025 {"city": "Pulaski", "state": "TN", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "route": ["ORAL"], "rxcui": ["205322", "205323"], "spl_id": ["5245a7d8-0271-b4bf-e063-6294a90a34a5"], "brand_name": ["CELECOXIB"], "spl_set_id": ["951df0f7-5fb7-40f5-e053-2995a90a1edd"], "package_ndc": ["50268-168-11", "50268-168-15", "50268-169-11", "50268-169-15"], "product_ndc": ["50268-168", "50268-169"], "generic_name": ["CELECOXIB"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["CELECOXIB"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"], "application_number": ["ANDA204519"], "original_packager_product_ndc": ["62332-141", "62332-142"]}, "event_id": "96888", "address_1": "615 N 1st St", "address_2": "", "code_info": "Lot #47881, Exp 05/31/2026", "postal_code": "38478-2403", "report_date": "20250618", "product_type": "Drugs", "recall_number": "D-0460-2025", "classification": "Class II", "more_code_info": "", "recalling_firm": "AvKARE", "product_quantity": "3,817 50-count cartons", "reason_for_recall": "Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20250513", "initial_firm_notification": "Letter", "center_classification_date": "20250609"} 2026-07-08 15:18:31.562162-07
+mrcl_01kx1wzb8av7z1rjk249379mhg user_steve med_01kx1wz68qy90y5epx0n25yx35 openFDA D-0478-2018 Class II Terminated CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 2018-02-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2018 {"city": "Waterford", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79149", "address_1": "6650 Highland Rd Ste 302", "address_2": "N/A", "code_info": "Lot #: a) 080515-2, Exp. 06/05/2019; b) 080515-1, Exp. 06/05/2019; c) 080515-1, Exp. 06/05/2019;", "postal_code": "48327-1665", "report_date": "20180228", "product_type": "Drugs", "recall_number": "D-0478-2018", "classification": "Class II", "recalling_firm": "American Pharmaceutical Ingredients LLC", "product_quantity": "48525 g", "termination_date": "20191202", "reason_for_recall": "CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327", "distribution_pattern": "Nationwide within USA.", "recall_initiation_date": "20180209", "initial_firm_notification": "Letter", "center_classification_date": "20180222"} 2026-07-08 15:18:31.562787-07
+mrcl_01kx1wzb8bxrqytbf2d96kzhm7 user_steve med_01kx1wz68qy90y5epx0n25yx35 openFDA D-570-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Celecoxib active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-570-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-570-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "2900 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Celecoxib active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:31.563233-07
+mrcl_01kx1wzbkz8z9jn5mbsqbwpmyf user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-0337-2015 Class II Terminated Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11 2014-12-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2015 {"city": "Elizabeth", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0731477272217"], "rxcui": ["310431"], "spl_id": ["b43e4780-f902-89d9-e053-2a95a90a6792"], "brand_name": ["GABA 300-EZS"], "spl_set_id": ["bb29692e-1546-4d05-a46a-93baf4172c7d"], "package_ndc": ["59088-725-00", "45963-556-11"], "product_ndc": ["59088-725"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "manufacturer_name": ["PureTek Corporation"], "is_original_packager": [true]}, "event_id": "70001", "address_1": "200 Elmora Ave", "address_2": "N/A", "code_info": "Lot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015", "postal_code": "07202-1106", "report_date": "20150114", "product_type": "Drugs", "recall_number": "D-0337-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Actavis Elizabeth LLC", "product_quantity": "24,240 Bottles", "termination_date": "20151120", "reason_for_recall": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11", "distribution_pattern": "Puerto Rico", "recall_initiation_date": "20141215", "initial_firm_notification": "Letter", "center_classification_date": "20150108"} 2026-07-08 15:18:31.935954-07
+mrcl_01kx1wzbm18x1mnj6vjkw5kwpa user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-0354-2023 Class III Terminated Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05. 2023-02-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2023 {"city": "Hauppauge", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0350228180108", "0350228180054", "0350228181013", "0350228178013", "0350228181051", "0350228179010", "0350228180016", "0350228177016", "0350228179102", "0350228178051", "0350228177054"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["176515ec-fdba-417a-b849-86aea6fd7857"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["5ab9c18b-9568-4dcb-90b0-252aef8f8dc2"], "package_ndc": ["50228-177-30", "50228-177-01", "50228-177-05", "50228-178-30", "50228-178-01", "50228-178-05"], "product_ndc": ["50228-177", "50228-178"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "application_number": ["ANDA205101"], "is_original_packager": [true]}, "event_id": "91717", "address_1": "89 Arkay Dr", "address_2": "N/A", "code_info": "Lot # G177092, Exp. 11/24", "postal_code": "11788-3727", "report_date": "20230308", "product_type": "Drugs", "recall_number": "D-0354-2023", "classification": "Class III", "more_code_info": "", "recalling_firm": "Sciegen Pharmaceuticals Inc", "product_quantity": "4,392 bottles", "termination_date": "20240617", "reason_for_recall": "Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20230217", "initial_firm_notification": "Letter", "center_classification_date": "20230227"} 2026-07-08 15:18:31.937485-07
+mrcl_01kx1wzbm27yfeg7nbftgbtnk5 user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-0208-2020 Class II Terminated Lack of Assurance of Sterility S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx 2019-08-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0208-2020 {"city": "Mesa", "state": "AZ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "83669", "address_1": "6828 E Brown Rd Ste 101", "address_2": "N/A", "code_info": "Lot #: S07312019DH@15, Exp 8/31/19", "postal_code": "85207-3761", "report_date": "20191113", "product_type": "Drugs", "recall_number": "D-0208-2020", "classification": "Class II", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "product_quantity": "N/A", "termination_date": "20230413", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20190812", "initial_firm_notification": "Letter", "center_classification_date": "20191105"} 2026-07-08 15:18:31.938519-07
+mrcl_01kx1wzbm3tzw9n4cae1gmhney user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-1232-2020 Class II Terminated CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99 2020-03-18 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1232-2020 {"city": "East Windsor", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["7a45ad84-02a4-442d-8401-1a1495d084fa"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["1a619a14-0b63-4cba-80e7-474c9a1c90b9"], "package_ndc": ["65862-198-01", "65862-198-05", "65862-198-99", "65862-198-10", "65862-198-90", "65862-198-18", "65862-198-27", "65862-199-01", "65862-199-05", "65862-199-99", "65862-199-10", "65862-199-30", "65862-199-60", "65862-199-90", "65862-199-18", "65862-199-27", "65862-200-01", "65862-200-05", "65862-200-10", "65862-200-90", "65862-200-27"], "product_ndc": ["65862-198", "65862-199", "65862-200"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Aurobindo Pharma Limited"], "application_number": ["ANDA078787"], "is_original_packager": [true]}, "event_id": "85183", "address_1": "279 Princeton Hightstown Rd", "address_2": "", "code_info": "Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021", "postal_code": "08520-1401", "report_date": "20200422", "product_type": "Drugs", "recall_number": "D-1232-2020", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aurobindo Pharma USA Inc.", "product_quantity": "26625 units", "termination_date": "20240325", "reason_for_recall": "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99", "distribution_pattern": "Nationwide within the United States", "recall_initiation_date": "20200318", "initial_firm_notification": "Letter", "center_classification_date": "20200413"} 2026-07-08 15:18:31.939614-07
+mrcl_01kx1wzcd7hn9nbrfc0nram0ff user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-070-2013 Class II Terminated Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90 2012-11-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-070-2013 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_id": ["536bd509-870a-5525-e063-6294a90a86cf"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["595ab888-6b55-4642-a32f-e8521821ed81"], "package_ndc": ["63304-828-90", "63304-828-05", "63304-827-90", "63304-827-05", "63304-829-90", "63304-829-05", "63304-830-90", "63304-830-05"], "product_ndc": ["63304-829", "63304-828", "63304-827", "63304-830"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Sun Pharmaceutical Industries Inc."], "application_number": ["ANDA076477"], "is_original_packager": [true]}, "event_id": "63759", "address_1": "600 College Rd E Ste 2100", "address_2": "N/A", "code_info": "Lot #s: 2436144, 2436582, 2441567, 2441568, Exp 08/31/2014.", "postal_code": "08540-6636", "report_date": "20121205", "product_type": "Drugs", "recall_number": "D-070-2013", "classification": "Class II", "recalling_firm": "Ranbaxy Inc.", "product_quantity": "120,201 Bottles", "termination_date": "20140428", "reason_for_recall": "Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90", "distribution_pattern": "Nationwide and PR", "recall_initiation_date": "20121109", "initial_firm_notification": "Letter", "center_classification_date": "20121129"} 2026-07-08 15:18:32.743981-07
+mrcl_01kx1wzcd9yjrty3gsa3fhqh8b user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0374-2023 Class II Terminated CGMP Deviations: recalling drug products following an FDA inspection. Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 2023-02-07 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0374-2023 {"city": "Durham", "state": "NC", "status": "Terminated", "country": "United States", "openfda": {"upc": ["316729047159", "316729047166"], "unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_id": ["40828d2e-69eb-5d38-e063-6394a90abd70"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["4e06b20d-cc5d-46eb-991b-5972248de3af"], "package_ndc": ["16729-045-10", "16729-045-15", "16729-045-01", "16729-045-16", "16729-045-17", "16729-044-10", "16729-044-15", "16729-044-01", "16729-044-16", "16729-044-17", "16729-046-10", "16729-046-15", "16729-046-01", "16729-046-16", "16729-046-17", "16729-047-10", "16729-047-15", "16729-047-01", "16729-047-16", "16729-047-17"], "product_ndc": ["16729-044", "16729-045", "16729-046", "16729-047"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Accord Healthcare Inc."], "application_number": ["ANDA207687"], "is_original_packager": [true]}, "event_id": "91657", "address_1": "1009 Slater Rd Ste 210B", "address_2": "N/A", "code_info": "Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023; R2100461, R2100463, R2100464, Exp. Date 3/31/2023; R2101214, R2101215, R2101216, Exp. Date 9/30/2023; R2101572, R2101573, R2101577, R2101578, R2101585, R2101579, R2101584, R2101587, R2101597, Exp. Date 11/30/2023; R2200801, Exp. Date 6/30/2024;", "postal_code": "27703-8446", "report_date": "20230308", "product_type": "Drugs", "recall_number": "D-0374-2023", "classification": "Class II", "more_code_info": "", "recalling_firm": "Accord Healthcare, Inc.", "product_quantity": "72,376 bottles", "termination_date": "20240422", "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA", "distribution_pattern": "United States including Puerto Rico and Canada", "recall_initiation_date": "20230207", "initial_firm_notification": "Letter", "center_classification_date": "20230302"} 2026-07-08 15:18:32.745358-07
+mrcl_01kx1wzbm46wekv6v73medzxx5 user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-696-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Gabapentin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-696-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-696-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "365402 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:31.940357-07
+mrcl_01kx1wzbm4zzx6p56p6qbzea0f user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-0031-2026 Class II Ongoing Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). 2025-10-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0031-2026 {"city": "Dublin", "state": "OH", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0055154336307", "0055154799201"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["b6880b32-3ebc-4b0e-8a84-d513f3e401af", "b64683a2-7521-4a16-8fc7-4974606e2e3b"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["36f74fdf-0dae-47a0-a7ea-e64ac91cd88f", "41844c21-9e2a-4332-a8ff-9b71ae9032b0"], "package_ndc": ["0904-6665-61", "0904-6666-61", "0904-6667-61", "55154-3363-0", "55154-7992-0", "55154-7993-0"], "product_ndc": ["0904-6665", "0904-6666", "0904-6667", "55154-3363", "55154-7992", "55154-7993"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Major Pharmaceuticals", "Cardinal Health 107, LLC"], "application_number": ["ANDA090858"], "original_packager_product_ndc": ["67877-222", "67877-223", "67877-224", "0904-6665", "0904-6666", "0904-6667"]}, "event_id": "97777", "address_1": "7000 Cardinal Pl", "address_2": "", "code_info": "Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.", "postal_code": "43017-1091", "report_date": "20251029", "product_type": "Drugs", "recall_number": "D-0031-2026", "classification": "Class II", "more_code_info": "", "recalling_firm": "The Harvard Drug Group LLC", "product_quantity": "", "reason_for_recall": "Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).", "distribution_pattern": "US Nationwide.", "recall_initiation_date": "20251010", "initial_firm_notification": "", "center_classification_date": "20251017"} 2026-07-08 15:18:31.941091-07
+mrcl_01kx1wzbm56nzjvgm56mdjv7rh user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-0320-2025 Class II Ongoing CGMP Deviations Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05. 2025-03-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2025 {"city": "Mahwah", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0368462127018", "0368462126011"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["4da1bae0-701b-4b65-a01e-f4bcedfad849"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["3865a6e3-112c-490c-82ac-35401336b16e"], "package_ndc": ["68462-126-01", "68462-126-05", "68462-127-01", "68462-127-05"], "product_ndc": ["68462-126", "68462-127"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA077662"], "is_original_packager": [true]}, "event_id": "96474", "address_1": "750 Corporate Dr", "address_2": "N/A", "code_info": "Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25", "postal_code": "07430-2009", "report_date": "20250416", "product_type": "Drugs", "recall_number": "D-0320-2025", "classification": "Class II", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "product_quantity": "N/A", "reason_for_recall": "CGMP Deviations", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.", "distribution_pattern": "U.S. Nationwide", "recall_initiation_date": "20250313", "initial_firm_notification": "Letter", "center_classification_date": "20250408"} 2026-07-08 15:18:31.941921-07
+mrcl_01kx1wzbm6c8173h3sm1xcycmb user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-0312-2025 Class III Ongoing Cross Contamination Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. 2025-03-04 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0312-2025 {"city": "Princeton", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0362756204010", "0362756202016", "0362756138025", "0362756137028", "0362756139022"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "spl_id": ["aff50a15-df39-495f-a145-0ba59660eed8"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["c9a05f0c-b5f0-422c-9d67-6d0efc921a74"], "package_ndc": ["62756-137-02", "62756-137-03", "62756-137-05", "62756-137-04", "62756-137-01", "62756-138-02", "62756-138-03", "62756-138-05", "62756-138-04", "62756-138-01", "62756-139-02", "62756-139-03", "62756-139-05", "62756-139-04", "62756-139-01", "62756-202-01", "62756-202-03", "62756-204-01", "62756-204-03"], "product_ndc": ["62756-137", "62756-138", "62756-139", "62756-202", "62756-204"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "application_number": ["ANDA077242"], "is_original_packager": [true]}, "event_id": "96415", "address_1": "2 Independence Way", "address_2": "N/A", "code_info": "Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025", "postal_code": "08540-6620", "report_date": "20250416", "product_type": "Drugs", "recall_number": "D-0312-2025", "classification": "Class III", "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "product_quantity": "852 bottles", "reason_for_recall": "Cross Contamination", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20250304", "initial_firm_notification": "Letter", "center_classification_date": "20250404"} 2026-07-08 15:18:31.942724-07
+mrcl_01kx1wzbm7szexrr6xahwj1xcw user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-329-2013 Class III Terminated Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. 2013-04-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-329-2013 {"city": "Mahwah", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0368462127018", "0368462126011"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["4da1bae0-701b-4b65-a01e-f4bcedfad849"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["3865a6e3-112c-490c-82ac-35401336b16e"], "package_ndc": ["68462-126-01", "68462-126-05", "68462-127-01", "68462-127-05"], "product_ndc": ["68462-126", "68462-127"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA077662"], "is_original_packager": [true]}, "event_id": "64995", "address_1": "750 Corporate Dr", "address_2": "", "code_info": "a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp 10/14 Lot# 02123430, Exp 10/14 Lot# 02123492, Exp 10/14 Lot# 02123523, Exp 10/14 Lot# 02123527, Exp 10/14 Lot# 02123532, Exp 10/14 Lot# 02123542, Exp 10/14 Lot# 02123546, Exp 10/14 Lot# 02123551, Exp 10/14 Lot# 02123555, Exp 10/14 Lot# 02123560, Exp 11/14 Lot# 02123566, Exp 11/14 Lot# 02123569, Exp 11/14 b) 800 mg Lot# 02123440 Exp 10/14 Lot# 02123445 Exp 10/14 Lot# 02123454 Exp 10/14 Lot# 02123465 Exp 10/14 Lot# 02123789 Exp 11/14 Lot# 02123804 Exp 11/14 Lot# 02123821 Exp 11/14 Lot# 02123829 Exp 11/14 Lot# 02123834 Exp 11/14 Lot# 02123841 Exp 11/14 Lot# 02123845 Exp 11/14", "postal_code": "07430-2009", "report_date": "20130522", "product_type": "Drugs", "recall_number": "D-329-2013", "classification": "Class III", "more_code_info": "", "recalling_firm": "Glenmark Generics Inc., USA", "product_quantity": "a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)", "termination_date": "20141009", "reason_for_recall": "Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20130405", "initial_firm_notification": "Letter", "center_classification_date": "20130516"} 2026-07-08 15:18:31.943681-07
+mrcl_01kx1wzbm8966mc8xykw7y04ve user_steve med_01kx1wz68q5hs5rgtajtfkx8rb openFDA D-0336-2015 Class II Terminated Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA. 2014-12-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2015 {"city": "Elizabeth", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0345963555113", "0345963556110"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["63f9a25b-d34f-4b4b-8ccd-e0f6dac569f5"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["5969871e-6c71-4c37-9d63-370718ccc80c"], "package_ndc": ["45963-555-11", "45963-555-50", "45963-556-11", "45963-556-50", "45963-557-11", "45963-557-50", "14550-513-02"], "product_ndc": ["45963-555", "45963-556", "45963-557"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Actavis Pharma, Inc."], "application_number": ["ANDA075350"], "is_original_packager": [true]}, "event_id": "70001", "address_1": "200 Elmora Ave", "address_2": "N/A", "code_info": "Lot #s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015", "postal_code": "07202-1106", "report_date": "20150114", "product_type": "Drugs", "recall_number": "D-0336-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Actavis Elizabeth LLC", "product_quantity": "10,857 Bottles", "termination_date": "20151120", "reason_for_recall": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.", "distribution_pattern": "Puerto Rico", "recall_initiation_date": "20141215", "initial_firm_notification": "Letter", "center_classification_date": "20150108"} 2026-07-08 15:18:31.944855-07
+mrcl_01kx1wzc0dfgrh96n1j09ms39c user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-0454-2025 Class II Ongoing cGMP deviations Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card). 2025-05-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0454-2025 {"city": "Columbus", "state": "OH", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["XXE1CET956"], "route": ["ORAL"], "rxcui": ["310992"], "spl_id": ["423d8198-e51f-90c2-e063-6294a90a1de7"], "brand_name": ["INDOMETHACIN"], "spl_set_id": ["5a65b650-ea9b-4d0d-b62f-5971df1e62b4"], "package_ndc": ["68084-411-11", "68084-411-21"], "product_ndc": ["68084-411"], "generic_name": ["INDOMETHACIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["INDOMETHACIN"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"], "application_number": ["ANDA079175"], "original_packager_product_ndc": ["10702-016"]}, "event_id": "96898", "address_1": "2550 John Glenn Ave Ste A", "address_2": "N/A", "code_info": "Lot #: 1021950, Exp. 11/30/2026", "postal_code": "43217-1188", "report_date": "20250611", "product_type": "Drugs", "recall_number": "D-0454-2025", "classification": "Class II", "recalling_firm": "Amerisource Health Services LLC", "product_quantity": "21 cartons", "reason_for_recall": "cGMP deviations", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20250515", "initial_firm_notification": "Letter", "center_classification_date": "20250602"} 2026-07-08 15:18:32.333452-07
+mrcl_01kx1wzc0e933v8gpc3ngz2xg3 user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-733-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Indomethacin Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-733-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-733-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "2500 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indomethacin Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:32.33412-07
+mrcl_01kx1wzct0czp77758a34kww37 user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-0655-2025 Class I Ongoing Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19. 2025-08-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2025 {"city": "East Brunswick", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"unii": ["0VE05JYS2P"], "route": ["ORAL"], "rxcui": ["828299", "828320", "828348"], "spl_id": ["cc113cd6-8904-4485-b1b2-15dd5ff7468b"], "brand_name": ["CYCLOBENZAPRINE HYDROCHLORIDE"], "spl_set_id": ["1adcdd8a-30f9-4a7b-853c-948a5589acab"], "package_ndc": ["29300-413-05", "29300-413-10", "29300-413-01", "29300-413-19", "29300-414-01", "29300-414-10", "29300-415-01", "29300-415-05", "29300-415-10", "29300-415-19"], "product_ndc": ["29300-413", "29300-414", "29300-415"], "generic_name": ["CYCLOBENZAPRINE HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["CYCLOBENZAPRINE HYDROCHLORIDE"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "application_number": ["ANDA213324"], "is_original_packager": [true]}, "event_id": "97482", "address_1": "1 Tower Center Blvd Ste 2200", "address_2": "N/A", "code_info": "Lot No: GMML24026A, Expires: 09/30/2027", "postal_code": "08816-1145", "report_date": "20250924", "product_type": "Drugs", "recall_number": "D-0655-2025", "classification": "Class I", "recalling_firm": "Unichem Pharmaceuticals USA Inc.", "product_quantity": "230 90-count bottles", "reason_for_recall": "Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.", "distribution_pattern": "Nationwide within the U.S.A", "recall_initiation_date": "20250827", "initial_firm_notification": "Press Release", "center_classification_date": "20250917"} 2026-07-08 15:18:33.152089-07
+mrcl_01kx1wzc0emgxcz82y8na8rrkm user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-1294-2014 Class II Terminated CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 2014-03-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1294-2014 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "67811", "address_1": "425 Privet Rd", "address_2": "", "code_info": "TE32134, Exp. 02/15", "postal_code": "19044-1220", "report_date": "20140521", "product_type": "Drugs", "recall_number": "D-1294-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "7,694 bottles", "termination_date": "20141114", "reason_for_recall": "CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01", "distribution_pattern": "Nationwide", "recall_initiation_date": "20140324", "initial_firm_notification": "Letter", "center_classification_date": "20140512"} 2026-07-08 15:18:32.334802-07
+mrcl_01kx1wzc0fhvj2zwbasn03xrva user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-0643-2024 Class II Ongoing Failed Dissolution Specifications: below specification results Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. 2024-07-31 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0643-2024 {"city": "Mahwah", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368462325605"], "unii": ["XXE1CET956"], "route": ["ORAL"], "rxcui": ["310992"], "spl_id": ["e729f88c-b2c8-4462-98be-7184de95b01d"], "brand_name": ["INDOMETHACIN"], "spl_set_id": ["532d40b2-c05c-4d4f-b7ee-e6434c4c27fc"], "package_ndc": ["68462-325-60", "68462-325-90", "68462-325-01", "68462-325-05", "68462-325-10"], "product_ndc": ["68462-325"], "generic_name": ["INDOMETHACIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["INDOMETHACIN"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA203501"], "is_original_packager": [true]}, "event_id": "95075", "address_1": "750 Corporate Dr", "address_2": "", "code_info": "Lot#: 17240105, Exp 12/31/2025", "postal_code": "07430-2009", "report_date": "20240904", "product_type": "Drugs", "recall_number": "D-0643-2024", "classification": "Class II", "more_code_info": "", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "product_quantity": "2404 bottles", "reason_for_recall": "Failed Dissolution Specifications: below specification results", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20240731", "initial_firm_notification": "", "center_classification_date": "20240823"} 2026-07-08 15:18:32.335435-07
+mrcl_01kx1wzc0gkahckh06efq6sy5a user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-0606-2018 Class III Terminated Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day. Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01. 2018-03-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0606-2018 {"city": "Mahwah", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368462406014", "0368462302019"], "unii": ["XXE1CET956"], "route": ["ORAL"], "rxcui": ["197817", "197818"], "spl_id": ["bcf62935-0bd5-479f-9680-c5b4eba5a529"], "brand_name": ["INDOMETHACIN"], "spl_set_id": ["f7ed39e2-5431-4e47-935c-c7441d058f94"], "package_ndc": ["68462-406-01", "68462-406-10", "68462-302-01", "68462-302-05"], "product_ndc": ["68462-302", "68462-406"], "generic_name": ["INDOMETHACIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["INDOMETHACIN"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA091276"], "is_original_packager": [true]}, "event_id": "79570", "address_1": "750 Corporate Dr", "address_2": "", "code_info": "Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.", "postal_code": "07430-2009", "report_date": "20180404", "product_type": "Drugs", "recall_number": "D-0606-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "product_quantity": "109,080 Bottles", "termination_date": "20191216", "reason_for_recall": "Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of \\"One or two capsules 2 or 3 times a day.\\" rather than the correct usual adult dosage of \\"One capsule 2 or 3 times a day.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.", "distribution_pattern": "Nationwide in the United States.", "recall_initiation_date": "20180319", "initial_firm_notification": "Letter", "center_classification_date": "20180326"} 2026-07-08 15:18:32.336137-07
+mrcl_01kx1wzc0hp6f5n8d27qj4z291 user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-0501-2017 Class II Terminated Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing. Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43 2017-02-07 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2017 {"city": "South Plainfield", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "76430", "address_1": "111 Coolidge St", "address_2": "N/A", "code_info": "Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018", "postal_code": "07080-3895", "report_date": "20170308", "product_type": "Drugs", "recall_number": "D-0501-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "G & W Laboratories, Inc.", "product_quantity": "3456 boxes", "termination_date": "20180618", "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43", "distribution_pattern": "Within United States", "recall_initiation_date": "20170207", "initial_firm_notification": "Letter", "center_classification_date": "20170301"} 2026-07-08 15:18:32.337162-07
+mrcl_01kx1wzc0haq73b504052y24be user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-0445-2025 Class II Ongoing cGMP deviations Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01. 2025-05-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2025 {"city": "Newtown", "state": "PA", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0310702016101", "0310702016033"], "unii": ["XXE1CET956"], "route": ["ORAL"], "rxcui": ["310992"], "spl_id": ["30a4fdec-3f89-034c-e063-6294a90aa786"], "brand_name": ["INDOMETHACIN"], "spl_set_id": ["dc80228c-acae-44dc-9762-19bd1669bf45"], "package_ndc": ["10702-016-03", "10702-016-06", "10702-016-09", "10702-016-01", "10702-016-50", "10702-016-10"], "product_ndc": ["10702-016"], "generic_name": ["INDOMETHACIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["INDOMETHACIN"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["KVK-Tech, Inc."], "application_number": ["ANDA079175"], "is_original_packager": [true]}, "event_id": "96847", "address_1": "110 Terry Dr", "address_2": "N/A", "code_info": "Lot#: 18400A, Exp 7/31/2027", "postal_code": "18940-3427", "report_date": "20250528", "product_type": "Drugs", "recall_number": "D-0445-2025", "classification": "Class II", "recalling_firm": "KVK Tech, Inc.", "product_quantity": "9107 bottles", "reason_for_recall": "cGMP deviations", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20250509", "initial_firm_notification": "E-Mail", "center_classification_date": "20250521"} 2026-07-08 15:18:32.337721-07
+mrcl_01kx1wzc0jv6awkbhjg3hxf7dg user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-1019-2018 Class II Terminated Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules. Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01. 2018-07-18 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1019-2018 {"city": "Hyderabad", "state": "N/A", "status": "Terminated", "country": "India", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0331722543019", "0331722542012"], "unii": ["XXE1CET956"], "route": ["ORAL"], "rxcui": ["197817", "197818"], "spl_id": ["349de484-29cd-3e15-e063-6394a90a5aa5"], "brand_name": ["INDOMETHACIN"], "spl_set_id": ["1ce9c3c5-0cf7-4760-988d-2559adcfb200"], "package_ndc": ["31722-542-30", "31722-542-01", "31722-542-05", "31722-542-10", "31722-543-30", "31722-543-01", "31722-543-05", "31722-543-10"], "product_ndc": ["31722-542", "31722-543"], "generic_name": ["INDOMETHACIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "substance_name": ["INDOMETHACIN"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "application_number": ["ANDA091240"], "is_original_packager": [true]}, "event_id": "80589", "address_1": "Plot 22-110, Part Ii, Ida", "address_2": "Rangareddy, Jeedimetla", "code_info": "Lot #: E180315, Exp 12/19", "postal_code": "N/A", "report_date": "20180808", "product_type": "Drugs", "recall_number": "D-1019-2018", "classification": "Class II", "recalling_firm": "Hetero Labs, Ltd. - Unit III", "product_quantity": "18,288 bottles", "termination_date": "20210715", "reason_for_recall": "Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20180718", "initial_firm_notification": "Letter", "center_classification_date": "20180727"} 2026-07-08 15:18:32.338258-07
+mrcl_01kx1wzc0jgfdp601dfzv6t52h user_steve med_01kx1wz68r9kwnpb0bgr86w7j4 openFDA D-1295-2014 Class II Terminated CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 2014-03-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1295-2014 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "67811", "address_1": "425 Privet Rd", "address_2": "", "code_info": "TE38139, Exp. 08/16, TE39022, Exp. 09/16,", "postal_code": "19044-1220", "report_date": "20140521", "product_type": "Drugs", "recall_number": "D-1295-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "5812 bottles", "termination_date": "20141114", "reason_for_recall": "CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960", "distribution_pattern": "Nationwide", "recall_initiation_date": "20140324", "initial_firm_notification": "Letter", "center_classification_date": "20140512"} 2026-07-08 15:18:32.338876-07
+mrcl_01kx1wzcd9k1e35bh4jrea4xx5 user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0020-2026 Class II Ongoing Failed Dissolution Specifications Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 2025-09-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2026 {"city": "Bedminster", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"upc": ["0367877512051", "0367877513102", "0367877514109"], "unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_id": ["777b866a-796a-4d15-8cb6-dd0c9a1856e2"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["67e60880-091a-4df7-8696-6e6c42a490e2"], "package_ndc": ["67877-511-90", "67877-511-05", "67877-511-10", "67877-511-55", "67877-511-33", "67877-511-38", "67877-512-90", "67877-512-05", "67877-512-10", "67877-512-44", "67877-512-33", "67877-512-38", "67877-513-90", "67877-513-05", "67877-513-10", "67877-513-23", "67877-513-33", "67877-513-38", "67877-514-90", "67877-514-05", "67877-514-10", "67877-514-33", "67877-514-38"], "product_ndc": ["67877-511", "67877-512", "67877-513", "67877-514"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Ascend Laboratories, LLC"], "application_number": ["ANDA209288"], "is_original_packager": [true]}, "event_id": "97639", "address_1": "135 Us Highway 202 206 Ste 15", "address_2": "", "code_info": "Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026", "postal_code": "07921-2608", "report_date": "20251022", "product_type": "Drugs", "recall_number": "D-0020-2026", "classification": "Class II", "more_code_info": "", "recalling_firm": "Ascend Laboratories, LLC", "product_quantity": "", "reason_for_recall": "Failed Dissolution Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054", "distribution_pattern": "U.S. Nationwide", "recall_initiation_date": "20250919", "initial_firm_notification": "Letter", "center_classification_date": "20251010"} 2026-07-08 15:18:32.746056-07
+mrcl_01kx1wzcdagynqm65dxjznrft2 user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-1143-2015 Class III Terminated Subpotent drug Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India 2015-05-06 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1143-2015 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0343598323305", "0343598315300", "0343598320304", "0343598317304", "0343598313306", "0343598322308", "0343598319308", "0343598316307", "0343598314303"], "unii": ["864V2Q084H", "48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["404011", "404013", "597967", "597971", "597974", "597977", "597980", "597984", "597987", "597990", "597993"], "spl_id": ["54058ac6-94e2-d2d3-5c46-886b3478fc76"], "brand_name": ["AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM"], "spl_set_id": ["abee4a34-89cc-d886-192c-32582ab8f024"], "package_ndc": ["43598-323-30", "43598-323-60", "43598-323-90", "43598-323-05", "43598-320-30", "43598-320-60", "43598-320-90", "43598-320-05", "43598-317-30", "43598-317-60", "43598-317-90", "43598-317-05", "43598-322-30", "43598-322-60", "43598-322-90", "43598-322-05", "43598-319-30", "43598-319-60", "43598-319-90", "43598-319-05", "43598-316-30", "43598-316-60", "43598-316-90", "43598-316-05", "43598-314-30", "43598-314-60", "43598-314-90", "43598-314-05", "43598-321-30", "43598-321-60", "43598-321-90", "43598-321-05", "43598-318-30", "43598-318-60", "43598-318-90", "43598-318-05", "43598-315-30", "43598-315-60", "43598-315-90", "43598-315-05", "43598-313-30", "43598-313-60", "43598-313-90", "43598-313-05"], "product_ndc": ["43598-313", "43598-323", "43598-320", "43598-317", "43598-322", "43598-319", "43598-316", "43598-314", "43598-321", "43598-318", "43598-315"], "generic_name": ["AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["AMLODIPINE BESYLATE", "ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc"], "application_number": ["ANDA203874"], "is_original_packager": [true]}, "event_id": "71375", "address_1": "107 College Rd E", "address_2": "", "code_info": "Lot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015", "postal_code": "08540-6623", "report_date": "20150624", "product_type": "Drugs", "recall_number": "D-1143-2015", "classification": "Class III", "more_code_info": "", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "", "termination_date": "20160331", "reason_for_recall": "Subpotent drug", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150506", "initial_firm_notification": "Letter", "center_classification_date": "20150618"} 2026-07-08 15:18:32.747037-07
+mrcl_01kx1wzcdb3pn6znnxxc7kp68e user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0511-2023 Class II Ongoing cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9 2023-03-23 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2023 {"city": "Anaheim", "state": "CA", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "91952", "address_1": "1250 N Lakeview Ave Ste O", "address_2": "", "code_info": "Lot #: A0523D, Exp 5/31/2024, F14220, Exp 7/31/2023, J0622Q; Exp 1/31/2024.", "postal_code": "92807-1801", "report_date": "20230412", "product_type": "Drugs", "recall_number": "D-0511-2023", "classification": "Class II", "more_code_info": "", "recalling_firm": "Preferred Pharmaceuticals, Inc.", "product_quantity": "158 Bottles", "reason_for_recall": "cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20230323", "initial_firm_notification": "Letter", "center_classification_date": "20230406"} 2026-07-08 15:18:32.747557-07
+mrcl_01kx1wzcdb6820hf7xnq3ede08 user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0418-2018 Class III Terminated Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05 2018-01-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0418-2018 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0355111123903"], "unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["617310", "617311", "617312"], "spl_id": ["36e09eff-3948-2638-b633-d5ec2bc03d2a"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["901550e6-22be-68c9-eb86-f85a9c9dd998"], "package_ndc": ["55111-121-30", "55111-121-60", "55111-121-90", "55111-121-05", "55111-121-10", "55111-122-30", "55111-122-60", "55111-122-90", "55111-122-05", "55111-122-10", "55111-123-30", "55111-123-60", "55111-123-90", "55111-123-05", "55111-123-10"], "product_ndc": ["55111-121", "55111-122", "55111-123"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "application_number": ["ANDA091650"], "is_original_packager": [true]}, "event_id": "79065", "address_1": "107 College Rd E", "address_2": "", "code_info": "Lot numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018", "postal_code": "08540-6623", "report_date": "20180207", "product_type": "Drugs", "recall_number": "D-0418-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "a) 34,125; b) 3,540 bottles", "termination_date": "20181207", "reason_for_recall": "Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05", "distribution_pattern": "Nationwide", "recall_initiation_date": "20180129", "initial_firm_notification": "Letter", "center_classification_date": "20180213"} 2026-07-08 15:18:32.748052-07
+mrcl_01kx1wzcdcxh5xn3dtcpkv0y46 user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0888-2018 Class III Terminated Failed Impurities/Degradation Specifications Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA 2018-06-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0888-2018 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0355111123903"], "unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["617310", "617311", "617312"], "spl_id": ["36e09eff-3948-2638-b633-d5ec2bc03d2a"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["901550e6-22be-68c9-eb86-f85a9c9dd998"], "package_ndc": ["55111-121-30", "55111-121-60", "55111-121-90", "55111-121-05", "55111-121-10", "55111-122-30", "55111-122-60", "55111-122-90", "55111-122-05", "55111-122-10", "55111-123-30", "55111-123-60", "55111-123-90", "55111-123-05", "55111-123-10"], "product_ndc": ["55111-121", "55111-122", "55111-123"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "application_number": ["ANDA091650"], "is_original_packager": [true]}, "event_id": "80275", "address_1": "107 College Rd E", "address_2": "N/A", "code_info": "Lot #: a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18", "postal_code": "08540-6623", "report_date": "20180627", "product_type": "Drugs", "recall_number": "D-0888-2018", "classification": "Class III", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "130,081 bottles", "termination_date": "20191108", "reason_for_recall": "Failed Impurities/Degradation Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20180612", "initial_firm_notification": "Letter", "center_classification_date": "20180621"} 2026-07-08 15:18:32.748896-07
+mrcl_01kx1wzct0wsc75nsq90bq4b0y user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-1036-2017 Class II Terminated Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15 2017-06-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1036-2017 {"city": "Fountain Run", "state": "KY", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77601", "address_1": "12954 Fountain Run Rd", "address_2": "N/A", "code_info": "Lot: 16710, exp 07/2018", "postal_code": "42133-7914", "report_date": "20170809", "product_type": "Drugs", "recall_number": "D-1036-2017", "classification": "Class II", "recalling_firm": "Apace KY LLC", "product_quantity": "N/A", "termination_date": "20180504", "reason_for_recall": "Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15", "distribution_pattern": "KY", "recall_initiation_date": "20170619", "initial_firm_notification": "E-Mail", "center_classification_date": "20170731"} 2026-07-08 15:18:33.152866-07
+mrcl_01kx1wzcddbp7d8rfhgx2ygb59 user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0887-2018 Class III Terminated Failed Impurities/Degradation Specifications Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 2018-06-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0887-2018 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0355111123903"], "unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["617310", "617311", "617312"], "spl_id": ["36e09eff-3948-2638-b633-d5ec2bc03d2a"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["901550e6-22be-68c9-eb86-f85a9c9dd998"], "package_ndc": ["55111-121-30", "55111-121-60", "55111-121-90", "55111-121-05", "55111-121-10", "55111-122-30", "55111-122-60", "55111-122-90", "55111-122-05", "55111-122-10", "55111-123-30", "55111-123-60", "55111-123-90", "55111-123-05", "55111-123-10"], "product_ndc": ["55111-121", "55111-122", "55111-123"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "application_number": ["ANDA091650"], "is_original_packager": [true]}, "event_id": "80275", "address_1": "107 College Rd E", "address_2": "N/A", "code_info": "Lot #: T600328, Exp 07/18; T700214, T700216, Exp 04/19", "postal_code": "08540-6623", "report_date": "20180627", "product_type": "Drugs", "recall_number": "D-0887-2018", "classification": "Class III", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "44,894 bottles", "termination_date": "20191108", "reason_for_recall": "Failed Impurities/Degradation Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20180612", "initial_firm_notification": "Letter", "center_classification_date": "20180621"} 2026-07-08 15:18:32.749877-07
+mrcl_01kx1wzcder3ba84vbd6xp07dz user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0618-2017 Class II Terminated Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. 2017-03-20 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0618-2017 {"city": "Morgantown", "state": "WV", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0303783953779", "0303783952772", "0303783950778", "0303783951775"], "unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_id": ["c94bf799-ec3d-4644-b1a2-3c7b3f612e19"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d"], "package_ndc": ["0378-3950-77", "0378-3950-05", "0378-3950-09", "0378-3950-07", "0378-3951-77", "0378-3951-05", "0378-3951-09", "0378-3951-07", "0378-3952-77", "0378-3952-05", "0378-3952-09", "0378-3952-07", "0378-3953-77", "0378-3953-05", "0378-3953-09", "0378-3953-07"], "product_ndc": ["0378-3950", "0378-3951", "0378-3952", "0378-3953"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "application_number": ["ANDA091226"], "is_original_packager": [true]}, "event_id": "76750", "address_1": "781 Chestnut Ridge Rd", "address_2": "", "code_info": "Lot #: a) 3076141, 3076142, Exp 05/18; 2007223, Exp 06/18; 2007335, Exp 07/18; 2007336, Exp 08/18; 2007446, 3084691, Exp 09/18; 3084692, Exp 01/18; b) 3073773, Exp 01/18; 2007445, Exp 09/18; c) 3076139, 3076140, 3076143, Exp 05/18; 3076144, 3076145, Exp 06/18; 2007445, Exp 09/18; d) 3070837, Exp 10/17; 3073773, Exp 01/18; 3076139, Exp 05/18; 3073774, Exp 01/18; 2007445, Exp 09/18", "postal_code": "26505-2730", "report_date": "20170405", "product_type": "Drugs", "recall_number": "D-0618-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "Mylan Pharmaceuticals Inc.", "product_quantity": "1,233,107 bottles", "termination_date": "20180126", "reason_for_recall": "Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20170320", "initial_firm_notification": "Telephone", "center_classification_date": "20170328"} 2026-07-08 15:18:32.750384-07
+mrcl_01kx1wzcdecc22y67a0c6eb5c4 user_steve med_01kx1wz68r2zk2vzytfayws9ab openFDA D-0373-2023 Class II Terminated CGMP Deviations: recalling drug products following an FDA inspection. Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 2023-02-07 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0373-2023 {"city": "Durham", "state": "NC", "status": "Terminated", "country": "United States", "openfda": {"upc": ["316729046152", "316729046176"], "unii": ["48A5M73Z4Q"], "route": ["ORAL"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_id": ["40828d2e-69eb-5d38-e063-6394a90abd70"], "brand_name": ["ATORVASTATIN CALCIUM"], "spl_set_id": ["4e06b20d-cc5d-46eb-991b-5972248de3af"], "package_ndc": ["16729-045-10", "16729-045-15", "16729-045-01", "16729-045-16", "16729-045-17", "16729-044-10", "16729-044-15", "16729-044-01", "16729-044-16", "16729-044-17", "16729-046-10", "16729-046-15", "16729-046-01", "16729-046-16", "16729-046-17", "16729-047-10", "16729-047-15", "16729-047-01", "16729-047-16", "16729-047-17"], "product_ndc": ["16729-044", "16729-045", "16729-046", "16729-047"], "generic_name": ["ATORVASTATIN CALCIUM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ATORVASTATIN CALCIUM TRIHYDRATE"], "manufacturer_name": ["Accord Healthcare Inc."], "application_number": ["ANDA207687"], "is_original_packager": [true]}, "event_id": "91657", "address_1": "1009 Slater Rd Ste 210B", "address_2": "N/A", "code_info": "Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024; R2200385, R2200386, R2200491, R2200490, R2200494, R2200496, R2200495, Exp. Date 3/31/2024; R2200510, R2200520, R2200521, R2200517, R2200511, R2200632, R2200631, R2200637, R2200635, R2200648, R2200638, R2200639, R2200647, Exp. Date 4/30/2024; R2200727, Exp. Date 5/31/2024;", "postal_code": "27703-8446", "report_date": "20230308", "product_type": "Drugs", "recall_number": "D-0373-2023", "classification": "Class II", "more_code_info": "", "recalling_firm": "Accord Healthcare, Inc.", "product_quantity": "147,736 bottles", "termination_date": "20240422", "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA", "distribution_pattern": "United States including Puerto Rico and Canada", "recall_initiation_date": "20230207", "initial_firm_notification": "Letter", "center_classification_date": "20230302"} 2026-07-08 15:18:32.750926-07
+mrcl_01kx1wzcswtj40fqn22h1z3tdr user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-0481-2018 Class II Terminated CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 2018-02-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0481-2018 {"city": "Waterford", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79149", "address_1": "6650 Highland Rd Ste 302", "address_2": "N/A", "code_info": "Lot #: a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020;", "postal_code": "48327-1665", "report_date": "20180228", "product_type": "Drugs", "recall_number": "D-0481-2018", "classification": "Class II", "recalling_firm": "American Pharmaceutical Ingredients LLC", "product_quantity": "123900 g", "termination_date": "20191202", "reason_for_recall": "CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327", "distribution_pattern": "Nationwide within USA.", "recall_initiation_date": "20180209", "initial_firm_notification": "Letter", "center_classification_date": "20180222"} 2026-07-08 15:18:33.148389-07
+mrcl_01kx1wzcswavntnfp5tzfvad5c user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-0775-2021 Class II Terminated CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01 2021-07-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0775-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88370", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "1408822A, exp. date 08/2023 (labeler - Casper)", "postal_code": "07054-1120", "report_date": "20210908", "product_type": "Drugs", "recall_number": "D-0775-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "4,587 bottles", "termination_date": "20221104", "reason_for_recall": "CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01", "distribution_pattern": "Product was distributed nationwide.", "recall_initiation_date": "20210729", "initial_firm_notification": "Letter", "center_classification_date": "20210827"} 2026-07-08 15:18:33.149063-07
+mrcl_01kx1wzebyaqw5tsrjy39j3pfm user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-1309-2022 Class II Terminated Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01 2022-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1309-2022 {"city": "Cherry Hill", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["238100", "238101", "1665188", "1665326"], "spl_id": ["329ddfc8-cf47-4584-a101-4727751e1005"], "brand_name": ["LORAZEPAM"], "spl_set_id": ["4084fa74-9fd2-45ef-9d56-27bfa31d4e46"], "package_ndc": ["0641-6048-01", "0641-6048-25", "0641-6050-01", "0641-6050-10", "0641-6049-01", "0641-6049-25", "0641-6051-01", "0641-6051-10"], "product_ndc": ["0641-6048", "0641-6050", "0641-6049", "0641-6051"], "generic_name": ["LORAZEPAM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Benzodiazepines [CS]"], "substance_name": ["LORAZEPAM"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "application_number": ["NDA018140"], "is_original_packager": [true]}, "event_id": "90583", "address_1": "2 Esterbrook Ln", "address_2": "", "code_info": "Lot # 070088, exp. date 07/2023", "postal_code": "08003-4002", "report_date": "20220817", "product_type": "Drugs", "recall_number": "D-1309-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Hikma Pharmaceuticals USA Inc.", "product_quantity": "713,550 vials", "termination_date": "20230914", "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20220711", "initial_firm_notification": "Letter", "center_classification_date": "20220805"} 2026-07-08 15:18:34.750142-07
+mrcl_01kx1wzcsx13kj2rtxbwd0g302 user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-605-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Cyclobenzaprine HCI active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-605-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-605-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "69860 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine HCI active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:33.149574-07
+mrcl_01kx1wzcsyxv31x32ndhq6w97h user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-0776-2021 Class II Terminated CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01 2021-07-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0776-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88370", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "1408824A, exp. date 08/2023 (labeler - Rising)", "postal_code": "07054-1120", "report_date": "20210908", "product_type": "Drugs", "recall_number": "D-0776-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "4,992 bottles", "termination_date": "20221104", "reason_for_recall": "CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01", "distribution_pattern": "Product was distributed nationwide.", "recall_initiation_date": "20210729", "initial_firm_notification": "Letter", "center_classification_date": "20210827"} 2026-07-08 15:18:33.150525-07
+mrcl_01kx1wzcszq28sqbq4kv13marr user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-0774-2021 Class II Terminated CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01 2021-07-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88370", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "1408821A, exp. date 08/2023 (labeler - Teva)", "postal_code": "07054-1120", "report_date": "20210908", "product_type": "Drugs", "recall_number": "D-0774-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "9,655 bottles", "termination_date": "20221104", "reason_for_recall": "CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01", "distribution_pattern": "Product was distributed nationwide.", "recall_initiation_date": "20210729", "initial_firm_notification": "Letter", "center_classification_date": "20210827"} 2026-07-08 15:18:33.151133-07
+mrcl_01kx1wzcszwnff3qvv2aabg0d2 user_steve med_01kx1wz68rbfpny7dxt43nztym openFDA D-972-2014 Class II Terminated Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD46257_62, EXP: 5/15/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD73525_1, EXP: 5/30/2014. CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-972-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "CYCLOBENZAPRINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD46265_4, 5/15/2014; Pedigree: AD73525_7, 5/30/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-972-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "300 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD46257_62, EXP: 5/15/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD73525_1, EXP: 5/30/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:33.151718-07
+mrcl_01kx1wzd6fbk8265vvx45trfbq user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-0481-2018 Class II Terminated CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 2018-02-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0481-2018 {"city": "Waterford", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79149", "address_1": "6650 Highland Rd Ste 302", "address_2": "N/A", "code_info": "Lot #: a) 081715-1, Exp. 2/29/2020; b) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; CBP1307004BVP-4102015, Exp. 4/30/2018; c) 010615-1, Exp. 6/30/2019; 081715-1, Exp. 2/29/2020 d) 010615-1, Exp. 6/30/2019; 051616-1, Exp.11/30/2020; 081715-1, Exp. 2/29/2020; 081715-2, Exp. 2/29/2020;", "postal_code": "48327-1665", "report_date": "20180228", "product_type": "Drugs", "recall_number": "D-0481-2018", "classification": "Class II", "recalling_firm": "American Pharmaceutical Ingredients LLC", "product_quantity": "123900 g", "termination_date": "20191202", "reason_for_recall": "CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327", "distribution_pattern": "Nationwide within USA.", "recall_initiation_date": "20180209", "initial_firm_notification": "Letter", "center_classification_date": "20180222"} 2026-07-08 15:18:33.551949-07
+mrcl_01kx1wzd6g5q1b29gf1j5n8zs8 user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-0775-2021 Class II Terminated CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01 2021-07-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0775-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88370", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "1408822A, exp. date 08/2023 (labeler - Casper)", "postal_code": "07054-1120", "report_date": "20210908", "product_type": "Drugs", "recall_number": "D-0775-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "4,587 bottles", "termination_date": "20221104", "reason_for_recall": "CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01", "distribution_pattern": "Product was distributed nationwide.", "recall_initiation_date": "20210729", "initial_firm_notification": "Letter", "center_classification_date": "20210827"} 2026-07-08 15:18:33.553015-07
+mrcl_01kx1wzd6hmanfnfgt7q48ndft user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-605-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Cyclobenzaprine HCI active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-605-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-605-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "69860 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine HCI active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:33.553908-07
+mrcl_01kx1wzd6jb5jd32936azegpsb user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-0776-2021 Class II Terminated CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01 2021-07-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0776-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88370", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "1408824A, exp. date 08/2023 (labeler - Rising)", "postal_code": "07054-1120", "report_date": "20210908", "product_type": "Drugs", "recall_number": "D-0776-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "4,992 bottles", "termination_date": "20221104", "reason_for_recall": "CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01", "distribution_pattern": "Product was distributed nationwide.", "recall_initiation_date": "20210729", "initial_firm_notification": "Letter", "center_classification_date": "20210827"} 2026-07-08 15:18:33.554692-07
+mrcl_01kx1wzd6kgrnwh9kq554gq9q7 user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-0774-2021 Class II Terminated CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01 2021-07-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88370", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "1408821A, exp. date 08/2023 (labeler - Teva)", "postal_code": "07054-1120", "report_date": "20210908", "product_type": "Drugs", "recall_number": "D-0774-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "9,655 bottles", "termination_date": "20221104", "reason_for_recall": "CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01", "distribution_pattern": "Product was distributed nationwide.", "recall_initiation_date": "20210729", "initial_firm_notification": "Letter", "center_classification_date": "20210827"} 2026-07-08 15:18:33.5553-07
+mrcl_01kx1wzd6kpqzcce31e62k92xm user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-972-2014 Class II Terminated Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD46257_62, EXP: 5/15/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD73525_1, EXP: 5/30/2014. CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-972-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "CYCLOBENZAPRINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD46265_4, 5/15/2014; Pedigree: AD73525_7, 5/30/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-972-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "300 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD46257_62, EXP: 5/15/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD73525_1, EXP: 5/30/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:33.556102-07
+mrcl_01kx1wzd6mn2bqvn07v2w138e3 user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-0655-2025 Class I Ongoing Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19. 2025-08-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2025 {"city": "East Brunswick", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"unii": ["0VE05JYS2P"], "route": ["ORAL"], "rxcui": ["828299", "828320", "828348"], "spl_id": ["cc113cd6-8904-4485-b1b2-15dd5ff7468b"], "brand_name": ["CYCLOBENZAPRINE HYDROCHLORIDE"], "spl_set_id": ["1adcdd8a-30f9-4a7b-853c-948a5589acab"], "package_ndc": ["29300-413-05", "29300-413-10", "29300-413-01", "29300-413-19", "29300-414-01", "29300-414-10", "29300-415-01", "29300-415-05", "29300-415-10", "29300-415-19"], "product_ndc": ["29300-413", "29300-414", "29300-415"], "generic_name": ["CYCLOBENZAPRINE HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["CYCLOBENZAPRINE HYDROCHLORIDE"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "application_number": ["ANDA213324"], "is_original_packager": [true]}, "event_id": "97482", "address_1": "1 Tower Center Blvd Ste 2200", "address_2": "N/A", "code_info": "Lot No: GMML24026A, Expires: 09/30/2027", "postal_code": "08816-1145", "report_date": "20250924", "product_type": "Drugs", "recall_number": "D-0655-2025", "classification": "Class I", "recalling_firm": "Unichem Pharmaceuticals USA Inc.", "product_quantity": "230 90-count bottles", "reason_for_recall": "Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.", "distribution_pattern": "Nationwide within the U.S.A", "recall_initiation_date": "20250827", "initial_firm_notification": "Press Release", "center_classification_date": "20250917"} 2026-07-08 15:18:33.556793-07
+mrcl_01kx1wzd6ndyb27ghrvzes6x63 user_steve med_01kx1wz68s55t5t2v9yk20wc0f openFDA D-1036-2017 Class II Terminated Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15 2017-06-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1036-2017 {"city": "Fountain Run", "state": "KY", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77601", "address_1": "12954 Fountain Run Rd", "address_2": "N/A", "code_info": "Lot: 16710, exp 07/2018", "postal_code": "42133-7914", "report_date": "20170809", "product_type": "Drugs", "recall_number": "D-1036-2017", "classification": "Class II", "recalling_firm": "Apace KY LLC", "product_quantity": "N/A", "termination_date": "20180504", "reason_for_recall": "Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15", "distribution_pattern": "KY", "recall_initiation_date": "20170619", "initial_firm_notification": "E-Mail", "center_classification_date": "20170731"} 2026-07-08 15:18:33.557442-07
+mrcl_01kx1wzdk8421y21yrrfcb7a5s user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-823-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Omeprazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-823-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-823-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "11250 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Omeprazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:33.960711-07
+mrcl_01kx1wzdk3m683k46zw6w7ksr2 user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-504-2014 Class II Terminated Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014. OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-504-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg has the following codes Pedigree: AD70655_20, EXP: 5/29/2014; Pedigree: AD73627_35, EXP: 5/30/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-504-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "210 Capsules", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:33.955878-07
+mrcl_01kx1wzdk54225bjvvm9ha566p user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-0525-2025 Class II Ongoing Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10 2025-06-30 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2025 {"city": "Princeton", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "route": ["ORAL"], "rxcui": ["198051"], "spl_id": ["17380ad5-9506-8e44-aa84-b6ce52ac7b9b"], "brand_name": ["OMEPRAZOLE"], "spl_set_id": ["665e9877-85ac-fdb6-54ac-1c47941ceab8"], "package_ndc": ["82009-022-10"], "product_ndc": ["82009-022"], "generic_name": ["OMEPRAZOLE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["OMEPRAZOLE"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "application_number": ["ANDA075576"], "is_original_packager": [true]}, "event_id": "97161", "address_1": "107 College Rd E", "address_2": "N/A", "code_info": "Lot: C2403017, Exp 12/31/2026", "postal_code": "08540-6623", "report_date": "20250723", "product_type": "Drugs", "recall_number": "D-0525-2025", "classification": "Class II", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "1476 bottles", "reason_for_recall": "Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20250630", "initial_firm_notification": "Letter", "center_classification_date": "20250714"} 2026-07-08 15:18:33.957436-07
+mrcl_01kx1wzdk6geq6wv6v420m2vha user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-0139-2017 Class III Terminated Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03 2016-10-20 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0139-2017 {"city": "Wilmington", "state": "MA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "75490", "address_1": "841 Woburn St", "address_2": "N/A", "code_info": "Lot #: E1396, Exp. 08/2018", "postal_code": "01887-3414", "report_date": "20161123", "product_type": "Drugs", "recall_number": "D-0139-2017", "classification": "Class III", "recalling_firm": "CutisPharma, Inc.", "product_quantity": "5904 kits", "termination_date": "20170912", "reason_for_recall": "Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03", "distribution_pattern": "Nationwide", "recall_initiation_date": "20161020", "initial_firm_notification": "Letter", "center_classification_date": "20161116"} 2026-07-08 15:18:33.958409-07
+mrcl_01kx1wzdk7s35369cmznt3zey5 user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-0026-2022 Class II Terminated CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle. Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1 2021-10-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0026-2022 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"unii": ["426QFE7XLK"], "route": ["ORAL"], "rxcui": ["198051"], "spl_id": ["7dcc8f17-f79a-325e-bb4f-181efdfc0457"], "brand_name": ["ACID REDUCER"], "spl_set_id": ["1dc00f13-d1f5-15a0-32cc-4fc041865e72"], "package_ndc": ["70000-0232-1", "70000-0232-2", "70000-0232-3"], "product_ndc": ["70000-0232"], "generic_name": ["OMEPRAZOLE MAGNESIUM"], "product_type": ["HUMAN OTC DRUG"], "substance_name": ["OMEPRAZOLE MAGNESIUM"], "manufacturer_name": ["LEADER/ Cardinal Health 110, Inc."], "application_number": ["ANDA078878"], "original_packager_product_ndc": ["55111-397"]}, "event_id": "88809", "address_1": "107 College Rd E", "address_2": "N/A", "code_info": "BT001594C", "postal_code": "08540-6623", "report_date": "20211027", "product_type": "Drugs", "recall_number": "D-0026-2022", "classification": "Class II", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "8,976 bottles", "termination_date": "20221206", "reason_for_recall": "CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20211005", "initial_firm_notification": "Letter", "center_classification_date": "20211022"} 2026-07-08 15:18:33.959254-07
+mrcl_01kx1wzdk7xj9zdqkqxamaby9d user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-0308-2021 Class II Terminated Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10 2021-03-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0308-2021 {"city": "Berlin", "state": "CT", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "87498", "address_1": "15 Massirio Dr Ste 201", "address_2": "N/A", "code_info": "Lot # 191659, exp. date 05/2021", "postal_code": "06037-2352", "report_date": "20210324", "product_type": "Drugs", "recall_number": "D-0308-2021", "classification": "Class II", "recalling_firm": "Breckenridge Pharmaceutical, Inc", "product_quantity": "3,146 bottles", "termination_date": "20220323", "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10", "distribution_pattern": "Product was distributed nationwide", "recall_initiation_date": "20210311", "initial_firm_notification": "Letter", "center_classification_date": "20210318"} 2026-07-08 15:18:33.959993-07
+mrcl_01kx1wzeby1gxjtwc6x189xyrp user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-0826-2023 Class II Ongoing CGMP Deviations: Firm went out of business and could no longer continue stability studies. Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs 2023-04-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0826-2023 {"city": "Gurnee", "state": "IL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "91788", "address_1": "5605 Centerpoint Ct Ste A", "address_2": "N/A", "code_info": "All Lots", "postal_code": "60031-5278", "report_date": "20230607", "product_type": "Drugs", "recall_number": "D-0826-2023", "classification": "Class II", "recalling_firm": "Akorn, Inc.", "product_quantity": "N/A", "reason_for_recall": "CGMP Deviations: Firm went out of business and could no longer continue stability studies.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20230426", "initial_firm_notification": "Letter", "center_classification_date": "20230601"} 2026-07-08 15:18:34.750474-07
+mrcl_01kx1wzdk90qx1fxv5p7a7sg5b user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-502-2014 Class II Terminated Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014. OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-502-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg has the following codes Pedigree: AD49399_4, EXP: 5/16/2014; Pedigree: AD46300_17, EXP: 5/15/2014; Pedigree: AD65457_22, EXP: 5/24/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-502-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "294 Capsules", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:33.961548-07
+mrcl_01kx1wzdkakdndvr49ajqaq6ah user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-0416-2019 Class II Terminated Lack of Processing Controls. Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07 2018-12-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2019 {"city": "Waynesboro", "state": "TN", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "81811", "address_1": "215 Dexter L Woods Memorial Blvd", "address_2": "N/A", "code_info": "N/A", "postal_code": "38485-2416", "report_date": "20190206", "product_type": "Drugs", "recall_number": "D-0416-2019", "classification": "Class II", "recalling_firm": "Duren Health Mart Pharmacy", "product_quantity": "2700 cc", "termination_date": "20220119", "reason_for_recall": "Lack of Processing Controls.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07", "distribution_pattern": "TN only", "recall_initiation_date": "20181217", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20190128"} 2026-07-08 15:18:33.96262-07
+mrcl_01kx1wzdkbaxjgkx952mtmd9n0 user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-0138-2017 Class III Terminated Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05 2016-10-20 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0138-2017 {"city": "Wilmington", "state": "MA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "75490", "address_1": "841 Woburn St", "address_2": "N/A", "code_info": "Lot #: E1414, Exp. 08/2018", "postal_code": "01887-3414", "report_date": "20161123", "product_type": "Drugs", "recall_number": "D-0138-2017", "classification": "Class III", "recalling_firm": "CutisPharma, Inc.", "product_quantity": "8,748 kits", "termination_date": "20170912", "reason_for_recall": "Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05", "distribution_pattern": "Nationwide", "recall_initiation_date": "20161020", "initial_firm_notification": "Letter", "center_classification_date": "20161116"} 2026-07-08 15:18:33.963298-07
+mrcl_01kx1wzdkbhg6p26fzsk7zvccs user_steve med_01kx1wz68s6sk7x61rjq6nwkrm openFDA D-0312-2021 Class II Terminated Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10 2021-03-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0312-2021 {"city": "Camarillo", "state": "CA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "87566", "address_1": "5187 Camino Ruiz", "address_2": "N/A", "code_info": "Lot #: GS029673, Exp. Date 5/2021", "postal_code": "93012-8601", "report_date": "20210331", "product_type": "Drugs", "recall_number": "D-0312-2021", "classification": "Class II", "more_code_info": "", "recalling_firm": "Golden State Medical Supply Inc.", "product_quantity": "N/A", "termination_date": "20210728", "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10", "distribution_pattern": "Sold to two wholesalers/distributors under government contract located in PA and TX", "recall_initiation_date": "20210319", "initial_firm_notification": "Letter", "center_classification_date": "20210324"} 2026-07-08 15:18:33.964113-07
+mrcl_01kx1wzdzbj5rkvejq3af57hzk user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-1172-2022 Class II Terminated Defective container: defect prevents product from dispensing as intended. Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16 2022-06-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1172-2022 {"city": "Lake Forest", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "90405", "address_1": "1925 W Field Ct Ste 300", "address_2": "", "code_info": "Lot #: 379073, 379079, Exp 9/30/2023", "postal_code": "60045-4862", "report_date": "20220706", "product_type": "Drugs", "recall_number": "D-1172-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Akorn, Inc.", "product_quantity": "44,400 bottles", "termination_date": "20240714", "reason_for_recall": "Defective container: defect prevents product from dispensing as intended.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20220613", "initial_firm_notification": "Letter", "center_classification_date": "20220630"} 2026-07-08 15:18:34.347091-07
+mrcl_01kx1wzdz7x9ehpfmy1shh1zzs user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0405-2015 Class II Terminated Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16. 2015-02-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0405-2015 {"city": "Lake Forest", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "70625", "address_1": "1925 W. Field Court, Suite 300", "address_2": "N/A", "code_info": "Lot #: 631639, Exp 01/2017.", "postal_code": "60045", "report_date": "20150311", "product_type": "Drugs", "recall_number": "D-0405-2015", "classification": "Class II", "recalling_firm": "Akorn, Inc.", "product_quantity": "44,448 bottles", "termination_date": "20171130", "reason_for_recall": "Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20150227", "initial_firm_notification": "Letter", "center_classification_date": "20150305"} 2026-07-08 15:18:34.343367-07
+mrcl_01kx1wzdz80m6zvv3zmt175ffa user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0424-2019 Class II Terminated Defective Container: Potential for broken glass in the neck area of the glass bottles. Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23. 2019-02-01 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0424-2019 {"city": "Morgantown", "state": "WV", "status": "Terminated", "country": "United States", "openfda": {"unii": ["0L591QR10I", "O2GMZ0LF5W"], "route": ["NASAL"], "rxcui": ["1797847", "1797849"], "spl_id": ["ed1f7ce9-ccfa-4e73-940f-14ea8166d524"], "brand_name": ["DYMISTA"], "spl_set_id": ["4c557ec4-c4cf-11df-851a-0800200c9a66"], "package_ndc": ["0037-0245-23"], "product_ndc": ["0037-0245"], "generic_name": ["AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["AZELASTINE HYDROCHLORIDE", "FLUTICASONE PROPIONATE"], "manufacturer_name": ["Viatris Specialty LLC"], "application_number": ["NDA202236"], "is_original_packager": [true]}, "event_id": "81980", "address_1": "781 Chestnut Ridge Rd", "address_2": "", "code_info": "Lot: GA70535, Exp. April 2019", "postal_code": "26505-2730", "report_date": "20190213", "product_type": "Drugs", "recall_number": "D-0424-2019", "classification": "Class II", "more_code_info": "", "recalling_firm": "Mylan Pharmaceuticals Inc.", "product_quantity": "10,390 bottles", "termination_date": "20190909", "reason_for_recall": "Defective Container: Potential for broken glass in the neck area of the glass bottles.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.", "distribution_pattern": "Nationwide in the USA.", "recall_initiation_date": "20190201", "initial_firm_notification": "Letter", "center_classification_date": "20190204"} 2026-07-08 15:18:34.344286-07
+mrcl_01kx1wzdz8rqmvfddvy7rcjw6z user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0023-2022 Class II Terminated Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06 2021-09-22 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0023-2022 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88738", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "AFR16A", "postal_code": "07054-1120", "report_date": "20211027", "product_type": "Drugs", "recall_number": "D-0023-2022", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "1,978 inhalers", "termination_date": "20230216", "reason_for_recall": "Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20210922", "initial_firm_notification": "Letter", "center_classification_date": "20211021"} 2026-07-08 15:18:34.344915-07
+mrcl_01kx1wzdz9nebjtfcdxab5z7e5 user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-690-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Fluticasone Propionate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-690-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-690-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "16770 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluticasone Propionate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:34.345359-07
+mrcl_01kx1wzdz9x46bxkdp5tcn50q2 user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0349-2024 Class II Ongoing CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15 2024-02-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0349-2024 {"city": "Camarillo", "state": "CA", "status": "Ongoing", "country": "United States", "openfda": {"unii": ["O2GMZ0LF5W"], "route": ["NASAL"], "rxcui": ["1797907"], "spl_id": ["445f82b2-8490-db0e-e063-6394a90ac737"], "brand_name": ["FLUTICASONE PROPIONATE"], "spl_set_id": ["db857d81-4b1e-42b8-972a-5bb8735d60f8"], "package_ndc": ["60429-195-15"], "product_ndc": ["60429-195"], "generic_name": ["FLUTICASONE PROPIONATE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUTICASONE PROPIONATE"], "manufacturer_name": ["Golden State Medical Supply, Inc."], "application_number": ["ANDA077538"], "is_original_packager": [true]}, "event_id": "94029", "address_1": "5187 Camino Ruiz", "address_2": "", "code_info": "Lot #: TX5275, Exp. Date: 10/31/2026.", "postal_code": "93012-8601", "report_date": "20240306", "product_type": "Drugs", "recall_number": "D-0349-2024", "classification": "Class II", "more_code_info": "", "recalling_firm": "Golden State Medical Supply Inc.", "product_quantity": "59,712 bottles", "reason_for_recall": "CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20240214", "initial_firm_notification": "Letter", "center_classification_date": "20240223"} 2026-07-08 15:18:34.346002-07
+mrcl_01kx1wzdzant96bdktba0kmjx4 user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0481-2021 Class II Terminated CGMP Deviations: Intermittent exposure to temperature excursion during storage. TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL 2021-03-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0481-2021 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {"unii": ["JS86977WNV", "40AHO2C6DG", "7AN603V4JV"], "route": ["RESPIRATORY (INHALATION)"], "rxcui": ["1945039", "1945044", "1945047", "1945048", "2395769", "2395771", "2395774", "2395775"], "spl_id": ["3adf47cb-c3b5-4fdb-9441-d90679b79687"], "brand_name": ["TRELEGY ELLIPTA"], "spl_set_id": ["b5a81d5a-4648-4c7a-951d-33c014a63c7e"], "package_ndc": ["0173-0887-10", "0173-0887-14", "0173-0887-61", "0173-0893-10", "0173-0893-14", "0173-0893-61"], "product_ndc": ["0173-0887", "0173-0893"], "generic_name": ["FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUTICASONE FUROATE", "UMECLIDINIUM BROMIDE", "VILANTEROL TRIFENATATE"], "manufacturer_name": ["GlaxoSmithKline LLC"], "application_number": ["NDA209482"], "is_original_packager": [true]}, "event_id": "87512", "address_1": "7000 Cardinal Pl", "address_2": "N/A", "code_info": "FN2J", "postal_code": "43017-1091", "report_date": "20210602", "product_type": "Drugs", "recall_number": "D-0481-2021", "classification": "Class II", "recalling_firm": "Cardinal Health Inc.", "product_quantity": "4065 CARTON", "termination_date": "20240617", "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL", "distribution_pattern": "FL, GA, SC", "recall_initiation_date": "20210315", "initial_firm_notification": "Letter", "center_classification_date": "20210524"} 2026-07-08 15:18:34.346482-07
+mrcl_01kx1wzdzb8hqefh27xrqsab1m user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0202-2024 Class II Terminated CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32 2022-01-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0202-2024 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {"unii": ["6EW8Q962A5", "O2GMZ0LF5W"], "route": ["RESPIRATORY (INHALATION)"], "rxcui": ["896184", "896209", "896228", "2110510", "2110513", "2110516"], "spl_id": ["03d33612-03b4-4a2c-ba86-47816db363ce"], "brand_name": ["WIXELA INHUB"], "spl_set_id": ["3beef422-8a07-4a45-9ba6-414511e4b7e2"], "package_ndc": ["0378-9320-32", "0378-9321-32", "0378-9322-32"], "product_ndc": ["0378-9320", "0378-9321", "0378-9322"], "generic_name": ["FLUTICASONE PROPIONATE AND SALMETEROL"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUTICASONE PROPIONATE", "SALMETEROL XINAFOATE"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "application_number": ["ANDA208891"], "is_original_packager": [true]}, "event_id": "89450", "address_1": "7200 Cardinal Pl W", "address_2": "", "code_info": "Batch 62002532", "postal_code": "43017-1094", "report_date": "20240103", "product_type": "Drugs", "recall_number": "D-0202-2024", "classification": "Class II", "more_code_info": "", "recalling_firm": "CARDINAL HEALTHCARE", "product_quantity": "1 unit", "termination_date": "20240929", "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20220126", "initial_firm_notification": "Letter", "center_classification_date": "20231226"} 2026-07-08 15:18:34.347581-07
+mrcl_01kx1wzdzcxp93bdwk4y3favd4 user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0022-2022 Class II Terminated Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08. 2021-09-22 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2022 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88738", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "AFR18A", "postal_code": "07054-1120", "report_date": "20211027", "product_type": "Drugs", "recall_number": "D-0022-2022", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "3,240 inhalers", "termination_date": "20230216", "reason_for_recall": "Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20210922", "initial_firm_notification": "Letter", "center_classification_date": "20211021"} 2026-07-08 15:18:34.348101-07
+mrcl_01kx1wzdzcmsge6zkwfmezg6qd user_steve med_01kx1wz68sx8t99p4zqwppc7y5 openFDA D-0182-2024 Class II Terminated CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1 2022-01-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2024 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {"unii": ["O2GMZ0LF5W"], "route": ["NASAL"], "rxcui": ["1797907"], "spl_id": ["de4b94c3-9864-33f5-8afe-ec494562de52"], "brand_name": ["FLUTICASONE PROPIONATE"], "spl_set_id": ["3830675d-b45e-fc97-1f73-674b1fc38c80"], "package_ndc": ["60505-0829-1"], "product_ndc": ["60505-0829"], "generic_name": ["FLUTICASONE PROPIONATE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUTICASONE PROPIONATE"], "manufacturer_name": ["Apotex Corp."], "application_number": ["ANDA077538"], "is_original_packager": [true]}, "event_id": "89450", "address_1": "7200 Cardinal Pl W", "address_2": "", "code_info": "Batch TE9159, TE8156", "postal_code": "43017-1094", "report_date": "20240103", "product_type": "Drugs", "recall_number": "D-0182-2024", "classification": "Class II", "more_code_info": "", "recalling_firm": "CARDINAL HEALTHCARE", "product_quantity": "6 units", "termination_date": "20240929", "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20220126", "initial_firm_notification": "Letter", "center_classification_date": "20231226"} 2026-07-08 15:18:34.348532-07
+mrcl_01kx1wzebt1pma8v6mvk9w76rh user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-0665-2022 Class II Terminated Lack of Assurance of Sterility Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. 2020-08-06 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0665-2022 {"city": "Statesville", "state": "NC", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "89773", "address_1": "3478 E Broad St", "address_2": "N/A", "code_info": "Lot #: 07312020@6 BUD: 8/7/2020", "postal_code": "28625-4523", "report_date": "20220323", "product_type": "Drugs", "recall_number": "D-0665-2022", "classification": "Class II", "recalling_firm": "Family Pharmacy of Statesville", "product_quantity": "1 bag", "termination_date": "20230815", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.", "distribution_pattern": "NC only", "recall_initiation_date": "20200806", "initial_firm_notification": "Telephone", "center_classification_date": "20220317"} 2026-07-08 15:18:34.746781-07
+mrcl_01kx1wzebvgz4jae63mvtkx28y user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-1308-2022 Class II Terminated Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01 2022-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1308-2022 {"city": "Cherry Hill", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["206819", "206820", "238100", "238101", "1665188", "1665190", "1665326", "1665327"], "spl_id": ["209b0091-c890-4f69-a693-d0594c2606fe"], "brand_name": ["ATIVAN"], "spl_set_id": ["5fc0e987-61c9-40c4-b0d5-fcea07c8733e"], "package_ndc": ["0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10"], "product_ndc": ["0641-6000", "0641-6003", "0641-6002", "0641-6001"], "generic_name": ["LORAZEPAM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Benzodiazepines [CS]"], "substance_name": ["LORAZEPAM"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "application_number": ["NDA018140"], "is_original_packager": [true]}, "event_id": "90583", "address_1": "2 Esterbrook Ln", "address_2": "", "code_info": "Lot # 060064Z, Exp. 06/2023", "postal_code": "08003-4002", "report_date": "20220817", "product_type": "Drugs", "recall_number": "D-1308-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Hikma Pharmaceuticals USA Inc.", "product_quantity": "301,400 vials", "termination_date": "20230914", "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20220711", "initial_firm_notification": "Letter", "center_classification_date": "20220805"} 2026-07-08 15:18:34.747759-07
+mrcl_01kx1wzebww2ap9z97a4bp9y32 user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-0226-2025 Class II Ongoing Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61 2025-01-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2025 {"city": "La Vergne", "state": "TN", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "route": ["ORAL"], "rxcui": ["197900", "197901", "197902"], "spl_id": ["6b6c2fbc-d12d-41d7-b49d-cf374c773cbd"], "brand_name": ["LORAZEPAM"], "spl_set_id": ["62f6eb3b-813d-4890-aca9-799b7fa890df"], "package_ndc": ["0904-6007-60", "0904-6007-61", "0904-6008-60", "0904-6008-61", "0904-6009-60", "0904-6009-61"], "product_ndc": ["0904-6007", "0904-6008", "0904-6009"], "generic_name": ["LORAZEPAM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Benzodiazepines [CS]"], "substance_name": ["LORAZEPAM"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"], "application_number": ["ANDA078203"], "original_packager_product_ndc": ["69315-904", "69315-905", "69315-906"]}, "event_id": "96151", "address_1": "341 Mason Rd", "address_2": "N/A", "code_info": "Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026.", "postal_code": "37086-3606", "report_date": "20250226", "product_type": "Drugs", "recall_number": "D-0226-2025", "classification": "Class II", "recalling_firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories", "product_quantity": "82,281 cartons", "reason_for_recall": "Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61", "distribution_pattern": "Nationwide U.S. and Puerto rico", "recall_initiation_date": "20250121", "initial_firm_notification": "Letter", "center_classification_date": "20250219"} 2026-07-08 15:18:34.748564-07
+mrcl_01kx1wzebxwxesnrpc21vbcz8p user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-0825-2023 Class II Ongoing CGMP Deviations: Firm went out of business and could no longer continue stability studies. Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs 2023-04-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0825-2023 {"city": "Gurnee", "state": "IL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "91788", "address_1": "5605 Centerpoint Ct Ste A", "address_2": "N/A", "code_info": "All Lots", "postal_code": "60031-5278", "report_date": "20230607", "product_type": "Drugs", "recall_number": "D-0825-2023", "classification": "Class II", "recalling_firm": "Akorn, Inc.", "product_quantity": "N/A", "reason_for_recall": "CGMP Deviations: Firm went out of business and could no longer continue stability studies.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20230426", "initial_firm_notification": "Letter", "center_classification_date": "20230601"} 2026-07-08 15:18:34.749444-07
+mrcl_01kx1wzebxtzg51nmn76e8ae1y user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-1566-2012 Class II Terminated Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. LORAZEPAM 2MG/ML INJECTABLE\t10 ML \t \t \t \t \t20 ML \t200 ML (3 DIFFERENT PRODUCTS) 2012-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1566-2012 {"city": "Ocala", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "62443", "address_1": "1210 SW 33rd Avenue", "address_2": "", "code_info": "Rx #'s:C0404989 C0398689 C0403441", "postal_code": "34474-5138", "report_date": "20120822", "product_type": "Drugs", "recall_number": "D-1566-2012", "classification": "Class II", "more_code_info": "", "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "product_quantity": "7 units", "termination_date": "20140815", "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "LORAZEPAM 2MG/ML INJECTABLE\\t10 ML \\t \\t \\t \\t \\t20 ML \\t200 ML (3 DIFFERENT PRODUCTS)", "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies", "recall_initiation_date": "20120521", "initial_firm_notification": "Letter", "center_classification_date": "20120810"} 2026-07-08 15:18:34.749772-07
+mrcl_01kx1wzebyb5hfaf0c8p8jbqyb user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-0253-2025 Class II Ongoing Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784. 2025-02-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0253-2025 {"city": "Columbus", "state": "OH", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "96308", "address_1": "4060 Business Park Dr Ste B", "address_2": "", "code_info": "Lot #s: a) 24210274, Exp 01/31/2025; 24401700, Exp 04/25/2025; b) 24251067, Exp 03/25/2025; 24421733, Exp 06/03/2025; c) 24261384, Exp 03/24/2025; 24370127, Exp 04/28/2025.", "postal_code": "43204-5047", "report_date": "20250312", "product_type": "Drugs", "recall_number": "D-0253-2025", "classification": "Class II", "more_code_info": "", "recalling_firm": "Safecor Health, LLC", "product_quantity": "3465 Oral Syringes", "reason_for_recall": "Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20250217", "initial_firm_notification": "Letter", "center_classification_date": "20250305"} 2026-07-08 15:18:34.750926-07
+mrcl_01kx1wzebzcva8aqbzkg504n01 user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-0085-2018 Class II Terminated Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05 2017-09-28 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0085-2018 {"city": "Fairfield", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0369315905104", "0369315904053", "0369315904107", "0369315906101", "0369315906057", "0369315905050", "0369315904015", "0369315905012", "0369315906019"], "unii": ["O26FZP769L"], "route": ["ORAL"], "rxcui": ["197900", "197901", "197902"], "spl_id": ["40249bb6-0d25-4b2f-aa4b-85c15af6bf8b"], "brand_name": ["LORAZEPAM"], "spl_set_id": ["5ca13415-4b77-4131-a9d2-6db26bc49167"], "package_ndc": ["69315-904-01", "69315-904-05", "69315-904-10", "69315-905-01", "69315-905-05", "69315-905-10", "69315-906-01", "69315-906-05", "69315-906-10"], "product_ndc": ["69315-904", "69315-905", "69315-906"], "generic_name": ["LORAZEPAM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Benzodiazepines [CS]"], "substance_name": ["LORAZEPAM"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "application_number": ["ANDA078203"], "is_original_packager": [true]}, "event_id": "78471", "address_1": "3 Oak Rd", "address_2": "N/A", "code_info": "Lot #E00717", "postal_code": "07004-2903", "report_date": "20171129", "product_type": "Drugs", "recall_number": "D-0085-2018", "classification": "Class II", "recalling_firm": "Leading Pharma, LLC", "product_quantity": "2952 500-count bottles", "termination_date": "20200921", "reason_for_recall": "Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20170928", "initial_firm_notification": "Letter", "center_classification_date": "20171120"} 2026-07-08 15:18:34.751436-07
+mrcl_01kx1wzec0jhqr0a4csxcztcn0 user_steve med_01kx1wz68seksn669d54z5kea6 openFDA D-1310-2022 Class II Terminated Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01 2022-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1310-2022 {"city": "Cherry Hill", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["238100", "238101", "1665188", "1665326"], "spl_id": ["7c73dbc6-2623-4443-9b05-97dec7a0be2e"], "brand_name": ["LORAZEPAM"], "spl_set_id": ["e9b54e42-04cf-4c62-90e1-36f7b31a4e81"], "package_ndc": ["0641-6044-01", "0641-6044-25", "0641-6046-01", "0641-6046-10", "0641-6045-01", "0641-6045-25", "0641-6047-01", "0641-6047-10"], "product_ndc": ["0641-6044", "0641-6046", "0641-6045", "0641-6047"], "generic_name": ["LORAZEPAM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Benzodiazepines [CS]"], "substance_name": ["LORAZEPAM"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "application_number": ["NDA018140"], "is_original_packager": [true]}, "event_id": "90583", "address_1": "2 Esterbrook Ln", "address_2": "", "code_info": "Lot # 070096, exp. date 07/2023", "postal_code": "08003-4002", "report_date": "20220817", "product_type": "Drugs", "recall_number": "D-1310-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Hikma Pharmaceuticals USA Inc.", "product_quantity": "82,700 vials", "termination_date": "20230914", "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20220711", "initial_firm_notification": "Letter", "center_classification_date": "20220805"} 2026-07-08 15:18:34.752156-07
+mrcl_01kx1wzeqnt347zay9d839wtan user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-058-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. 2012-09-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-058-2013 {"city": "Corona", "state": "CA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63246", "address_1": "311 Bonnie Cir", "address_2": "N/A", "code_info": "Lot #: 519406A, 521759A, Exp 04/14", "postal_code": "92880-2882", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-058-2013", "classification": "Class I", "recalling_firm": "Watson Laboratories Inc", "product_quantity": "4,874 bottles", "termination_date": "20140324", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20120921", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:35.126084-07
+mrcl_01kx1wzeqpjwjn10bfdm8j1ee7 user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-0599-2018 Class III Terminated Failed Impurities/Degradation Specifications Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038 2018-03-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2018 {"city": "Somerset", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0343386118038", "343386118038"], "unii": ["68JRS2HC1C", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["992656"], "spl_id": ["116df522-26b7-42de-8c0b-16cc60c2e764"], "brand_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "spl_set_id": ["41ac90b3-f007-4eb2-9d41-ea626ced2017"], "package_ndc": ["43386-118-03", "43386-118-01", "43386-118-05", "3433861180"], "product_ndc": ["43386-118"], "generic_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["HOMATROPINE METHYLBROMIDE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "application_number": ["ANDA091528"], "is_original_packager": [true]}, "event_id": "79298", "address_1": "400 Campus Dr", "address_2": "", "code_info": "M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);", "postal_code": "08873-1145", "report_date": "20180321", "product_type": "Drugs", "recall_number": "D-0599-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Novel Laboratories, Inc.", "product_quantity": "134,364 bottles (4,030,920 tablets)", "termination_date": "20200608", "reason_for_recall": "Failed Impurities/Degradation Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038", "distribution_pattern": "Nationwide", "recall_initiation_date": "20180305", "initial_firm_notification": "Letter", "center_classification_date": "20180314"} 2026-07-08 15:18:35.126702-07
+mrcl_01kx1wzeqs8zha5e51zvfkmcxw user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-1517-2019 Class II Terminated Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. 2019-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2019 {"city": "Monmouth Junction", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0327808086013"], "unii": ["V1Q0O9OJ9Z", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["1087459"], "spl_id": ["b3ac95d4-bef9-4e32-9822-73b9534c9869"], "brand_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "spl_set_id": ["25f400d9-1d6e-4d38-8f0d-98d471eba73b"], "package_ndc": ["27808-086-02", "27808-086-01", "27808-086-03"], "product_ndc": ["27808-086"], "generic_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["CHLORPHENIRAMINE MALEATE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "application_number": ["ANDA091632"], "is_original_packager": [true]}, "event_id": "83346", "address_1": "2033 US Highway 130", "address_2": "N/A", "code_info": "Lot#: 14079, Exp 10/2021", "postal_code": "08852-3003", "report_date": "20190731", "product_type": "Drugs", "recall_number": "D-1517-2019", "classification": "Class II", "recalling_firm": "Tris Pharma Inc.", "product_quantity": "2,550 bottles", "termination_date": "20211102", "reason_for_recall": "Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20190711", "initial_firm_notification": "Letter", "center_classification_date": "20190724"} 2026-07-08 15:18:35.12945-07
+mrcl_01kx1wzeqqkh0fa9hxzj2pdkke user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-0276-2022 Class II Terminated Product Mix-up Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01. 2021-11-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2022 {"city": "Central Islip", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0331722997010", "0331722996013"], "unii": ["362O9ITL9D", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["856999", "857002"], "spl_id": ["d745e0ac-ee48-44c7-8430-8da0a69d2735"], "brand_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "spl_set_id": ["ed6af366-753c-4f3b-a6a2-c9a183c50035"], "package_ndc": ["31722-996-01", "31722-996-05", "31722-997-01", "31722-997-05"], "product_ndc": ["31722-996", "31722-997"], "generic_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ACETAMINOPHEN", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "application_number": ["ANDA211487"], "is_original_packager": [true]}, "event_id": "89060", "address_1": "400 S Technology Dr", "address_2": "N/A", "code_info": "Lot #: 21070817, Exp 6/2023", "postal_code": "11722-4402", "report_date": "20211215", "product_type": "Drugs", "recall_number": "D-0276-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Ascent Pharmaceuticals, Inc.", "product_quantity": "9744 bottles", "termination_date": "20231206", "reason_for_recall": "Product Mix-up", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20211119", "initial_firm_notification": "Letter", "center_classification_date": "20211207"} 2026-07-08 15:18:35.127197-07
+mrcl_01kx1wzeqqy03vb31dnnsjrbsn user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-1383-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1383-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18B013, Exp. 02/2020; 18E024; 18E030, Exp. 05/2020.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1383-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "11,112 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:35.12791-07
+mrcl_01kx1wzeqrccgk75279b98re1b user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-138-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. 2012-12-06 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-138-2013 {"city": "Huntsville", "state": "AL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63818", "address_1": "120 Vintage Dr NE", "address_2": "", "code_info": "Lot #: All that begin with the letter \\"C\\" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20130206", "product_type": "Drugs", "recall_number": "D-138-2013", "classification": "Class I", "more_code_info": "", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "897,379 bottles", "termination_date": "20210720", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20121206", "initial_firm_notification": "Press Release", "center_classification_date": "20130130"} 2026-07-08 15:18:35.12838-07
+mrcl_01kx1wzeqr67v784mcyaw0pax7 user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-1384-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1384-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1384-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "7,728 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:35.128874-07
+mrcl_01kx1wzeqs1n14sptweznp1fff user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-057-2013 Class I Ongoing Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 2012-09-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-057-2013 {"city": "Huntsville", "state": "AL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "63138", "address_1": "120 Vintage Dr NE", "address_2": "N/A", "code_info": "Lot number: C1440512A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-057-2013", "classification": "Class I", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "14,445 bottles", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21", "distribution_pattern": "Nationwide.", "recall_initiation_date": "20120910", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:35.129192-07
+mrcl_01kx1wzeqs6tymnmzkz72vgb64 user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-609-2014 Class II Terminated Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014. HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-609-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg has the following code Pedigree: W004005, EXP: 7/1/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-609-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:35.129843-07
+mrcl_01kx1wzeqty832q850qtrxzkzq user_steve med_01kx1wz68tzvrbcazn94z2mzq9 openFDA D-1139-2017 Class III Terminated Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16 2017-08-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2017 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77998", "address_1": "7265 Ulmerton Rd", "address_2": "N/A", "code_info": "Lot: 494700 Exp. 10/2018", "postal_code": "33771-4809", "report_date": "20170920", "product_type": "Drugs", "recall_number": "D-1139-2017", "classification": "Class III", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "3084 bottles", "termination_date": "20190311", "reason_for_recall": "Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16", "distribution_pattern": "Nationwide", "recall_initiation_date": "20170817", "initial_firm_notification": "Letter", "center_classification_date": "20170912"} 2026-07-08 15:18:35.130596-07
+mrcl_01kx1wzfge9ty43648zkntcypt user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-0154-2024 Class II Ongoing Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3 2023-12-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0154-2024 {"city": "Saint Paul", "state": "MN", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "93594", "address_1": "2400 Pilot Knob Rd", "address_2": "N/A", "code_info": "Lot#: 230308-U46196, Exp. date 04/30/2025", "postal_code": "55120-1118", "report_date": "20231227", "product_type": "Drugs", "recall_number": "D-0154-2024", "classification": "Class II", "recalling_firm": "Fagron, Inc", "product_quantity": "13 containers", "reason_for_recall": "Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3", "distribution_pattern": "Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.", "recall_initiation_date": "20231211", "initial_firm_notification": "Letter", "center_classification_date": "20231221"} 2026-07-08 15:18:35.919029-07
+mrcl_01kx1wzfgfcy4r59kem96ck2gj user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-0824-2020 Class II Terminated Subpotent: Out of specification for assay at the 12-month time point. Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16 2020-01-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0824-2020 {"city": "Greenville", "state": "SC", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0301210810022"], "unii": ["BDF1O1C72E"], "route": ["ORAL"], "rxcui": ["312055"], "spl_id": ["d57cde69-0eb9-180d-e053-2995a90a33aa"], "brand_name": ["NYSTATIN"], "spl_set_id": ["31e3da10-5a7b-4bc5-8a4f-3e786b64c13a"], "package_ndc": ["0121-0810-02", "0121-0810-16", "0121-4810-05", "0121-4810-40", "0121-4810-00", "0121-4810-50"], "product_ndc": ["0121-0810", "0121-4810"], "generic_name": ["NYSTATIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Polyenes [CS]"], "substance_name": ["NYSTATIN"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Pharmaceutical Associates, Inc."], "application_number": ["ANDA203621"], "is_original_packager": [true]}, "event_id": "84712", "address_1": "1700 Perimeter Rd", "address_2": "N/A", "code_info": "Lots: BB70, BB71 Exp. May 2020", "postal_code": "29605-5252", "report_date": "20200205", "product_type": "Drugs", "recall_number": "D-0824-2020", "classification": "Class II", "recalling_firm": "Pharmaceutical Associates Inc", "product_quantity": "6288 16 oz bottles", "termination_date": "20210603", "reason_for_recall": "Subpotent: Out of specification for assay at the 12-month time point.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16", "distribution_pattern": "Distributed Nationwide in the US", "recall_initiation_date": "20200114", "initial_firm_notification": "Letter", "center_classification_date": "20200203"} 2026-07-08 15:18:35.920069-07
+mrcl_01kx1wzfgggsea8he2ggs5rm86 user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-0007-2019 Class II Terminated Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing. Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India 2018-09-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2019 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "81083", "address_1": "107 College Rd E", "address_2": "", "code_info": "Lot #: a) D06017, D06018, Exp 9/18; D06028 Exp 10/18; b) D06014, D06015, D06016, Exp 9/18; D06024, D06025, D06026, D06027, Exp 10/2018; c) D06011, D06012, D06013, Exp 9/18; D06020, D06021, D06022, D06023, Exp 10/2018", "postal_code": "08540-6623", "report_date": "20181010", "product_type": "Drugs", "recall_number": "D-0007-2019", "classification": "Class II", "more_code_info": "", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "35020 tubes", "termination_date": "20230217", "reason_for_recall": "Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India", "distribution_pattern": "U.S.A. Nationwide", "recall_initiation_date": "20180921", "initial_firm_notification": "Letter", "center_classification_date": "20181004"} 2026-07-08 15:18:35.920907-07
+mrcl_01kx1wzgn6k263kyttb7tzgp79 user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-1545-2014 Class II Terminated CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01 2014-08-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2014 {"city": "Melrose Park", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0363323604004"], "unii": ["F8A3652H1V"], "route": ["INTRAVENOUS"], "rxcui": ["856443"], "spl_id": ["505851c4-b18c-4cd7-805c-4e923cc1fa7e"], "brand_name": ["PROPRANOLOL"], "spl_set_id": ["f14ea537-dd5c-4c78-9037-9a85e9e610ef"], "package_ndc": ["63323-604-01"], "product_ndc": ["63323-604"], "generic_name": ["PROPRANOLOL HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["PROPRANOLOL HYDROCHLORIDE"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "application_number": ["ANDA075826"], "is_original_packager": [true]}, "event_id": "68910", "address_1": "2045 Cornell Ave", "address_2": "", "code_info": "Lot 6007698, Exp. 03/16", "postal_code": "60160-1002", "report_date": "20140827", "product_type": "Drugs", "recall_number": "D-1545-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Fresenius Kabi USA, LLC", "product_quantity": "56,060 vials", "termination_date": "20160524", "reason_for_recall": "CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20140813", "initial_firm_notification": "Letter", "center_classification_date": "20140819"} 2026-07-08 15:18:37.094598-07
+mrcl_01kx1wzfghk433t07w8xx14e43 user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-1059-2017 Class II Terminated Presence of Foreign Substance: potential presence of plastic particles. Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61 2017-05-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2017 {"city": "Horseheads", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77834", "address_1": "300 Daniel Zenker Dr", "address_2": "N/A", "code_info": "Lot #: 23701.158A, EXP 10/31/18", "postal_code": "14845-1014", "report_date": "20170816", "product_type": "Drugs", "recall_number": "D-1059-2017", "classification": "Class II", "recalling_firm": "X-Gen Pharmaceuticals Inc.", "product_quantity": "9,816 bottles", "termination_date": "20180905", "reason_for_recall": "Presence of Foreign Substance: potential presence of plastic particles.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61", "distribution_pattern": "Nationwide in the US", "recall_initiation_date": "20170517", "initial_firm_notification": "Letter", "center_classification_date": "20170809"} 2026-07-08 15:18:35.921572-07
+mrcl_01kx1wzfgjc6fzw69dnp0meyym user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-0155-2024 Class II Ongoing Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9 2023-12-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2024 {"city": "Saint Paul", "state": "MN", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "93594", "address_1": "2400 Pilot Knob Rd", "address_2": "N/A", "code_info": "Lot #: 230308-U46225, Exp. date 04/30/2025, 221031-U42110, Exp. date 04/30/2025", "postal_code": "55120-1118", "report_date": "20231227", "product_type": "Drugs", "recall_number": "D-0155-2024", "classification": "Class II", "recalling_firm": "Fagron, Inc", "product_quantity": "46 containers", "reason_for_recall": "Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9", "distribution_pattern": "Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.", "recall_initiation_date": "20231211", "initial_firm_notification": "Letter", "center_classification_date": "20231221"} 2026-07-08 15:18:35.922417-07
+mrcl_01kx1wzfgjjs1nc1xah62kjx1z user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-1338-2020 Class II Terminated Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30 2020-06-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1338-2020 {"city": "Johnson City", "state": "TN", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0303160221156"], "unii": ["BDF1O1C72E"], "route": ["TOPICAL"], "rxcui": ["543546"], "spl_id": ["48342e66-405b-57be-e063-6394a90a276c"], "brand_name": ["NYSTATIN CREAM"], "spl_set_id": ["5a2b6fee-1437-0c3a-e053-2991aa0a3443"], "package_ndc": ["0316-0221-15", "0316-0221-30"], "product_ndc": ["0316-0221"], "generic_name": ["NYSTATIN CREAM"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Polyenes [CS]"], "substance_name": ["NYSTATIN"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Crown Laboratories"], "application_number": ["ANDA207733"], "is_original_packager": [true]}, "event_id": "85833", "address_1": "349 Lafe Cox Dr", "address_2": "N/A", "code_info": "Lot: Y0378A, EXP 07/2021", "postal_code": "37604-7469", "report_date": "20200701", "product_type": "Drugs", "recall_number": "D-1338-2020", "classification": "Class II", "recalling_firm": "Crown Laboratories", "product_quantity": "62,274 tubes", "termination_date": "20211105", "reason_for_recall": "Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30", "distribution_pattern": "Distributed Nationwide in the USA.", "recall_initiation_date": "20200610", "initial_firm_notification": "Letter", "center_classification_date": "20200624"} 2026-07-08 15:18:35.923076-07
+mrcl_01kx1wzfgm0nxf7k1c6s5takek user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-0676-2017 Class II Terminated Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532 2017-03-28 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0676-2017 {"city": "Hawthorne", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "unii": ["BDF1O1C72E", "F446C597KA"], "route": ["TOPICAL"], "rxcui": ["1053697", "1053753"], "spl_id": ["395e7f1c-ecc8-31cf-e063-6294a90aef62"], "brand_name": ["NYSTATIN AND TRIAMCINOLONE ACETONIDE"], "spl_set_id": ["2fd97fc5-cae5-43dd-a3c7-c9a03876153e"], "package_ndc": ["51672-1272-1", "51672-1272-2", "51672-1272-3", "51672-1263-1", "51672-1263-2", "51672-1263-3"], "product_ndc": ["51672-1263", "51672-1272"], "generic_name": ["NYSTATIN AND TRIAMCINOLONE ACETONIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Polyenes [CS]"], "substance_name": ["NYSTATIN", "TRIAMCINOLONE ACETONIDE"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "application_number": ["ANDA062364"], "is_original_packager": [true]}, "event_id": "76954", "address_1": "3 Skyline Dr", "address_2": "N/A", "code_info": "a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018", "postal_code": "10532-2174", "report_date": "20170426", "product_type": "Drugs", "recall_number": "D-0676-2017", "classification": "Class II", "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.", "product_quantity": "278,304 tubes", "termination_date": "20190617", "reason_for_recall": "Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20170328", "initial_firm_notification": "Letter", "center_classification_date": "20170420"} 2026-07-08 15:18:35.924437-07
+mrcl_01kx1wzfgnae32qf1svhr55r33 user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-1494-2020 Class II Terminated Subpotent drug: Out of specification for assay at the 15-month test interval. Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16 2020-08-04 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1494-2020 {"city": "Greenville", "state": "SC", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0301210810022"], "unii": ["BDF1O1C72E"], "route": ["ORAL"], "rxcui": ["312055"], "spl_id": ["d57cde69-0eb9-180d-e053-2995a90a33aa"], "brand_name": ["NYSTATIN"], "spl_set_id": ["31e3da10-5a7b-4bc5-8a4f-3e786b64c13a"], "package_ndc": ["0121-0810-02", "0121-0810-16", "0121-4810-05", "0121-4810-40", "0121-4810-00", "0121-4810-50"], "product_ndc": ["0121-0810", "0121-4810"], "generic_name": ["NYSTATIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Polyenes [CS]"], "substance_name": ["NYSTATIN"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Pharmaceutical Associates, Inc."], "application_number": ["ANDA203621"], "is_original_packager": [true]}, "event_id": "86170", "address_1": "1700 Perimeter Rd", "address_2": "N/A", "code_info": "Lot: B973, Exp 11/20", "postal_code": "29605-5252", "report_date": "20200819", "product_type": "Drugs", "recall_number": "D-1494-2020", "classification": "Class II", "recalling_firm": "PAI Holdings, LLC. dba Pharmaceutical Associates Inc", "product_quantity": "7416 bottles", "termination_date": "20210922", "reason_for_recall": "Subpotent drug: Out of specification for assay at the 15-month test interval.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20200804", "initial_firm_notification": "Letter", "center_classification_date": "20200812"} 2026-07-08 15:18:35.925298-07
+mrcl_01kx1wzfgp6xtr5wsjrp1vcd94 user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-0869-2017 Class III Terminated Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771. 2017-05-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2017 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77319", "address_1": "7265 Ulmerton Rd", "address_2": "", "code_info": "a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.", "postal_code": "33771-4809", "report_date": "20170607", "product_type": "Drugs", "recall_number": "D-0869-2017", "classification": "Class III", "more_code_info": "", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "2,208,500 cups/18696 bottles", "termination_date": "20200113", "reason_for_recall": "Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.", "distribution_pattern": "Nationwide in the US and Puerto Rico", "recall_initiation_date": "20170517", "initial_firm_notification": "Letter", "center_classification_date": "20170531"} 2026-07-08 15:18:35.926299-07
+mrcl_01kx1wzfgq5jn3tqpxe16ztdx8 user_steve med_01kx1wz68ttfvytr3qch61s3ef openFDA D-0865-2018 Class III Terminated Resuspension problems: Out of specification for appearance and resuspendability. Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05 2018-05-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0865-2018 {"city": "Greenville", "state": "SC", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0301210810022"], "unii": ["BDF1O1C72E"], "route": ["ORAL"], "rxcui": ["312055"], "spl_id": ["d57cde69-0eb9-180d-e053-2995a90a33aa"], "brand_name": ["NYSTATIN"], "spl_set_id": ["31e3da10-5a7b-4bc5-8a4f-3e786b64c13a"], "package_ndc": ["0121-0810-02", "0121-0810-16", "0121-4810-05", "0121-4810-40", "0121-4810-00", "0121-4810-50"], "product_ndc": ["0121-0810", "0121-4810"], "generic_name": ["NYSTATIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Polyenes [CS]"], "substance_name": ["NYSTATIN"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Pharmaceutical Associates, Inc."], "application_number": ["ANDA203621"], "is_original_packager": [true]}, "event_id": "80190", "address_1": "201 Delaware St", "address_2": "N/A", "code_info": "Lot: B5B8 Exp. 07/2019", "postal_code": "29605-5823", "report_date": "20180613", "product_type": "Drugs", "recall_number": "D-0865-2018", "classification": "Class III", "recalling_firm": "Pharmaceutical Associates Inc", "product_quantity": "275400 cups", "termination_date": "20200113", "reason_for_recall": "Resuspension problems: Out of specification for appearance and resuspendability.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05", "distribution_pattern": "Nationwide", "recall_initiation_date": "20180529", "initial_firm_notification": "Letter", "center_classification_date": "20180613"} 2026-07-08 15:18:35.927253-07
+mrcl_01kx1wzfwpeaqrysatcekx7kcz user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-871-2014 Class II Terminated Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014; FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014. FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-871-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "FLUCONAZOLE, Tablet, 200 mg has the following codes: Pedigree: AD65475_16, EXP: 5/28/2014; Pedigree: W003065, EXP: 6/12/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-871-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "200 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014; FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:36.310513-07
+mrcl_01kx1wzfwqvj3yv204n5s08nf5 user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-0614-2017 Class II Terminated Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06 2017-03-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0614-2017 {"city": "North Brunswick", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "76733", "address_1": "1445 US Highway 130", "address_2": "", "code_info": "Lot #: A051052, Exp. Aug 2017", "postal_code": "08902-3100", "report_date": "20170405", "product_type": "Drugs", "recall_number": "D-0614-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "Claris Lifesciences Inc", "product_quantity": "18,096 units (3016 cartons x 6 bags)", "termination_date": "20200918", "reason_for_recall": "Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06", "distribution_pattern": "Nationwide", "recall_initiation_date": "20170310", "initial_firm_notification": "Letter", "center_classification_date": "20170324"} 2026-07-08 15:18:36.311406-07
+mrcl_01kx1wzfwr1djp4wygds8c13pp user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-1121-2016 Class II Terminated Lack of Processing Controls All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. 2016-03-25 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1121-2016 {"city": "San Francisco", "state": "CA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "73662", "address_1": "801 Irving St", "address_2": "N/A", "code_info": "All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.", "postal_code": "94122-2310", "report_date": "20160713", "product_type": "Drugs", "recall_number": "D-1121-2016", "classification": "Class II", "recalling_firm": "Reliable Rexall-A Compounding Pharmacy", "product_quantity": "N/A", "termination_date": "20170410", "reason_for_recall": "Lack of Processing Controls", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.", "distribution_pattern": "U.S. Including: CA, HI, NM", "recall_initiation_date": "20160325", "initial_firm_notification": "Press Release", "center_classification_date": "20160706"} 2026-07-08 15:18:36.312257-07
+mrcl_01kx1wzfwrt9qgyzjvp8f1w9dr user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-0696-2018 Class II Terminated Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags. Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10 2018-02-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0696-2018 {"city": "Lakewood", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79580", "address_1": "1200 Paco Way", "address_2": "", "code_info": "Lot #: A0A0539, Exp. 05/19", "postal_code": "08701-5938", "report_date": "20180425", "product_type": "Drugs", "recall_number": "D-0696-2018", "classification": "Class II", "more_code_info": "", "recalling_firm": "Renaissance Lakewood, LLC", "product_quantity": "1784 bags", "termination_date": "20190814", "reason_for_recall": "Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10", "distribution_pattern": "Product was distributed throughout the United States.", "recall_initiation_date": "20180221", "initial_firm_notification": "Letter", "center_classification_date": "20180424"} 2026-07-08 15:18:36.312702-07
+mrcl_01kx1wzfwse7m15dpmkyamhwhg user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-728-2014 Class II Terminated Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014. FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-728-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "FLUCONAZOLE, Tablet, 50 mg has the following code Pedigree: W003066, EXP: 6/12/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-728-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "29 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:36.313179-07
+mrcl_01kx1wzfwsbv34p2p7b37hbf48 user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-0380-2015 Class II Terminated Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446. 2014-12-23 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0380-2015 {"city": "Deerfield", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "route": ["INTRAVENOUS"], "rxcui": ["1721314", "1721315"], "spl_id": ["36e35cdf-c4a0-428a-879e-1d65e2b66f64"], "brand_name": ["FLUCONAZOLE"], "spl_set_id": ["cd24a261-9c15-42b4-8040-89d2dbda174e"], "package_ndc": ["0338-6046-48", "0338-6045-37"], "product_ndc": ["0338-6045", "0338-6046"], "generic_name": ["FLUCONAZOLE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Azoles [CS]"], "substance_name": ["FLUCONAZOLE"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Baxter Healthcare Company"], "application_number": ["ANDA076766"], "is_original_packager": [true]}, "event_id": "70057", "address_1": "1 Baxter Pkwy", "address_2": "N/A", "code_info": "Lot #: P318394; Exp 05/31/16", "postal_code": "60015-4625", "report_date": "20150204", "product_type": "Drugs", "recall_number": "D-0380-2015", "classification": "Class II", "recalling_firm": "Baxter Healthcare Corp.", "product_quantity": "31,130 bags", "termination_date": "20160421", "reason_for_recall": "Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.", "distribution_pattern": "Nationwide, United Arab Emirates, and Columbia", "recall_initiation_date": "20141223", "initial_firm_notification": "Letter", "center_classification_date": "20150126"} 2026-07-08 15:18:36.313536-07
+mrcl_01kx1wzfwsvs475svy7wthwmzf user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-0689-2017 Class II Terminated Failed Dissolution Specifications Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61 2017-01-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0689-2017 {"city": "Livonia", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "route": ["ORAL"], "rxcui": ["197698", "197700"], "spl_id": ["3c6a1b79-df4e-4281-959e-8f41c97b13c0"], "brand_name": ["FLUCONAZOLE"], "spl_set_id": ["13184b13-e252-4b4d-a3e2-cfc4ad3d55b7"], "package_ndc": ["0904-6500-06", "0904-6500-61", "0904-6501-06", "0904-6501-61"], "product_ndc": ["0904-6500", "0904-6501"], "generic_name": ["FLUCONAZOLE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Azoles [CS]"], "substance_name": ["FLUCONAZOLE"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"], "application_number": ["ANDA076658"], "original_packager_product_ndc": ["55111-144", "55111-146"]}, "event_id": "77106", "address_1": "17177 N Laurel Park Dr Ste 233", "address_2": "", "code_info": "Lot #:T-00519, Exp. 01-17", "postal_code": "48152-3951", "report_date": "20170510", "product_type": "Drugs", "recall_number": "D-0689-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "The Harvard Drug Group", "product_quantity": "914 cartons", "termination_date": "20170804", "reason_for_recall": "Failed Dissolution Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61", "distribution_pattern": "Nationwide within the US", "recall_initiation_date": "20170105", "initial_firm_notification": "Letter", "center_classification_date": "20170428"} 2026-07-08 15:18:36.313985-07
+mrcl_01kx1wzfwtt5cp892q3ekw3q0s user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-0688-2017 Class II Terminated Failed Dissolution Specifications Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61 2017-01-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0688-2017 {"city": "Livonia", "state": "MI", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "route": ["ORAL"], "rxcui": ["197698", "197700"], "spl_id": ["3c6a1b79-df4e-4281-959e-8f41c97b13c0"], "brand_name": ["FLUCONAZOLE"], "spl_set_id": ["13184b13-e252-4b4d-a3e2-cfc4ad3d55b7"], "package_ndc": ["0904-6500-06", "0904-6500-61", "0904-6501-06", "0904-6501-61"], "product_ndc": ["0904-6500", "0904-6501"], "generic_name": ["FLUCONAZOLE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Azoles [CS]"], "substance_name": ["FLUCONAZOLE"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"], "application_number": ["ANDA076658"], "original_packager_product_ndc": ["55111-144", "55111-146"]}, "event_id": "77106", "address_1": "17177 N Laurel Park Dr Ste 233", "address_2": "", "code_info": "Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17", "postal_code": "48152-3951", "report_date": "20170510", "product_type": "Drugs", "recall_number": "D-0688-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "The Harvard Drug Group", "product_quantity": "2,341 cartons", "termination_date": "20170804", "reason_for_recall": "Failed Dissolution Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61", "distribution_pattern": "Nationwide within the US", "recall_initiation_date": "20170105", "initial_firm_notification": "Letter", "center_classification_date": "20170428"} 2026-07-08 15:18:36.31445-07
+mrcl_01kx1wzh24vwgg5jyjq5amxw24 user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-1589-2012 Class II Terminated Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE\t200 ML \t40 ML \t400 ML \t48 ML \t600 ML \t800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE\t20 ML \t \t \t \t200 ML \t24 ML \t40 ML \t48 ML (11 DIFFERENT PRODUCTS) 2012-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1589-2012 {"city": "Ocala", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "62443", "address_1": "1210 SW 33rd Avenue", "address_2": "", "code_info": "Rx #'s: 0403973 0408102 0403973 0409770 0403973 0403973 0400158 0400507 0400959 0402186 0398525 0400507 0400959 0398520 0400995 0400997", "postal_code": "34474-5138", "report_date": "20120822", "product_type": "Drugs", "recall_number": "D-1589-2012", "classification": "Class II", "more_code_info": "", "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab", "product_quantity": "16 units", "termination_date": "20140815", "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE\\t200 ML \\t40 ML \\t400 ML \\t48 ML \\t600 ML \\t800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE\\t20 ML \\t \\t \\t \\t200 ML \\t24 ML \\t40 ML \\t48 ML (11 DIFFERENT PRODUCTS)", "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies", "recall_initiation_date": "20120521", "initial_firm_notification": "Letter", "center_classification_date": "20120810"} 2026-07-08 15:18:37.508815-07
+mrcl_01kx1wzfwv8stkcz1wbm9d03c7 user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-1033-2018 Class III Terminated Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06. 2018-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1033-2018 {"city": "Lakewood", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "80442", "address_1": "1200 Paco Way", "address_2": "N/A", "code_info": "Lot #: a) A060966, A060967, A060965, A061023, Exp 07/18; b) A060962, Exp 02/19", "postal_code": "08701-5938", "report_date": "20180808", "product_type": "Drugs", "recall_number": "D-1033-2018", "classification": "Class III", "recalling_firm": "Renaissance Lakewood, LLC", "product_quantity": "12088 bags", "termination_date": "20220309", "reason_for_recall": "Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20180711", "initial_firm_notification": "Letter", "center_classification_date": "20180802"} 2026-07-08 15:18:36.315136-07
+mrcl_01kx1wzfwv2hm0rbnc4jke1yqf user_steve med_01kx1wz68tna4pfdq0f3w03hft openFDA D-0788-2017 Class II Terminated Lack of assurance of sterility: customer complaints received for the presence of leaks. Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48 2017-05-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2017 {"city": "Deerfield", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "unii": ["8VZV102JFY"], "route": ["INTRAVENOUS"], "rxcui": ["1721314", "1721315"], "spl_id": ["36e35cdf-c4a0-428a-879e-1d65e2b66f64"], "brand_name": ["FLUCONAZOLE"], "spl_set_id": ["cd24a261-9c15-42b4-8040-89d2dbda174e"], "package_ndc": ["0338-6046-48", "0338-6045-37"], "product_ndc": ["0338-6045", "0338-6046"], "generic_name": ["FLUCONAZOLE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_cs": ["Azoles [CS]"], "substance_name": ["FLUCONAZOLE"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Baxter Healthcare Company"], "application_number": ["ANDA076766"], "is_original_packager": [true]}, "event_id": "77247", "address_1": "1 Baxter Pkwy", "address_2": "", "code_info": "Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18", "postal_code": "60015-4625", "report_date": "20170524", "product_type": "Drugs", "recall_number": "D-0788-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "Baxter Healthcare Corporation", "product_quantity": "113,590 bags", "termination_date": "20180810", "reason_for_recall": "Lack of assurance of sterility: customer complaints received for the presence of leaks.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48", "distribution_pattern": "US and foreign countries: United Arab Emirates, Colombia, and Canada", "recall_initiation_date": "20170515", "initial_firm_notification": "", "center_classification_date": "20170518"} 2026-07-08 15:18:36.315799-07
+mrcl_01kx1wzgn5r1ykqge49z8xnf79 user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-514-2014 Class II Terminated Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PIOGLITAZONE HCL, Tablet, 15 mg, NDC 00093204856, Pedigree: AD52778_70, EXP: 5/21/2014. PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714002104 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-514-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PROPRANOLOL HCL, Tablet, 10 mg has the following code Pedigree: AD52778_73, EXP: 5/21/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-514-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PIOGLITAZONE HCL, Tablet, 15 mg, NDC 00093204856, Pedigree: AD52778_70, EXP: 5/21/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714002104", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:37.093129-07
+mrcl_01kx1wzgn59nz1t514s939chdk user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-993-2014 Class II Terminated Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, Pedigree: AD60243_1, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003068, EXP: 6/12/2014. PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-993-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PROPRANOLOL HCL, Tablet, 10 mg has the following codes: Pedigree: AD60264_1, EXP: 5/22/2014; Pedigree: W003032, EXP: 6/12/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-993-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "200 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, Pedigree: AD60243_1, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003068, EXP: 6/12/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:37.093788-07
+mrcl_01kx1wzgn65s0w9bk66mv31xgz user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-0022-2015 Class II Terminated cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004 2014-07-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2015 {"city": "Westbury", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "69243", "address_1": "135 Cantiague Rock Rd", "address_2": "N/A", "code_info": "Lot Number: 154919, Exp 11/2014", "postal_code": "11590-2826", "report_date": "20141022", "product_type": "Drugs", "recall_number": "D-0022-2015", "classification": "Class II", "recalling_firm": "Gyma Laboratories Of Amer,Inc", "product_quantity": "1 Kg", "termination_date": "20180604", "reason_for_recall": "cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004", "distribution_pattern": "Nationwide", "recall_initiation_date": "20140709", "initial_firm_notification": "E-Mail", "center_classification_date": "20141010"} 2026-07-08 15:18:37.094244-07
+mrcl_01kx1wzgn7ks9dtj6955g178ya user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-885-2014 Class II Terminated Labeling: Label Mixup: PROPRANOLOL HCL ER, Capsule, 60 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD52778_82, EXP: 5/21/2014. PROPRANOLOL HCL ER, Capsule, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00228277811. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-885-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PROPRANOLOL HCL ER, Capsule, 60 mg has the following codes: Pedigree: AD54605_4, EXP: 5/20/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-885-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Capsules", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: PROPRANOLOL HCL ER, Capsule, 60 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD52778_82, EXP: 5/21/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROPRANOLOL HCL ER, Capsule, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00228277811.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:37.095276-07
+mrcl_01kx1wzgn7h0vf61by58g8cwca user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-530-2014 Class II Terminated Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014. PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-530-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PROPRANOLOL HCL, Tablet, 5 mg (1/2 of 10 mg) has the following code Pedigree: AD73525_25, EXP: 5/30/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-530-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "198 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:37.095678-07
+mrcl_01kx1wzgn8h5stmz78pf65c9bb user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-532-2014 Class II Terminated Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD42584_12, EXP: 5/14/2014. PROPRANOLOL HCL Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011401 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-532-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PROPRANOLOL HCL, Tablet, 80 mg has the following code Pedigree: AD42566_4, EXP: 5/14/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-532-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD42584_12, EXP: 5/14/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROPRANOLOL HCL Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011401", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:37.09629-07
+mrcl_01kx1wzgn8vrybns987h6dchmb user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-0194-2024 Class II Terminated CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1 2022-01-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0194-2024 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0369238208016", "0369238207712", "0369238208115", "0369238207910", "0369238207811"], "unii": ["F8A3652H1V"], "route": ["ORAL"], "rxcui": ["856448", "856457", "856519", "856556", "856578"], "spl_id": ["0f5168af-0988-4aa1-91dc-7c66758e18a8"], "brand_name": ["PROPRANOLOL HYDROCHLORIDE"], "spl_set_id": ["14d0c95d-418f-40a8-bad3-e20c82424960"], "package_ndc": ["69238-2077-1", "69238-2077-7", "69238-2078-1", "69238-2078-7", "69238-2079-1", "69238-2079-7", "69238-2080-1", "69238-2081-1", "69238-2081-5"], "product_ndc": ["69238-2077", "69238-2078", "69238-2079", "69238-2080", "69238-2081"], "generic_name": ["PROPRANOLOL HYDROCHLORIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["PROPRANOLOL HYDROCHLORIDE"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "application_number": ["ANDA071972"], "is_original_packager": [true]}, "event_id": "89450", "address_1": "7200 Cardinal Pl W", "address_2": "", "code_info": "Batch 100023596", "postal_code": "43017-1094", "report_date": "20240103", "product_type": "Drugs", "recall_number": "D-0194-2024", "classification": "Class II", "more_code_info": "", "recalling_firm": "CARDINAL HEALTHCARE", "product_quantity": "2 units", "termination_date": "20240929", "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20220126", "initial_firm_notification": "Letter", "center_classification_date": "20231226"} 2026-07-08 15:18:37.096788-07
+mrcl_01kx1wzgn9gtjamt27e9jke3m2 user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-529-2014 Class II Terminated Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-529-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "PROPRANOLOL HCL Tablet, 10 mg has the following codes Pedigree: AD21790_34, EXP: 5/1/2014; Pedigree: AD52390_1, EXP: 5/17/2014; Pedigree: AD60272_37, EXP: 5/22/2014; Pedigree: W002732, EXP: 6/6/2014; Pedigree: W003229, EXP: 6/17/2014; Pedigree: AD60272_34, EXP: 5/22/2014; Pedigree: W003684, EXP: 6/25/2014; Pedigree: W002618, EXP: 6/4/2014; Pedigree: W003002, EXP: 6/11/2014; Pedigree: W003068, EXP: 6/12/2014; Pedigree: W003545, EXP: 6/21/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-529-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "2,299 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:37.097366-07
+mrcl_01kx1wzgn9e1ymzze7g25hk83w user_steve med_01kx1wz68vzbbna5yskv33rqm7 openFDA D-924-2013 Class II Terminated Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification. Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03 2013-08-06 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-924-2013 {"city": "Sellersville", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65912", "address_1": "650 Cathill Rd", "address_2": "", "code_info": "Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016", "postal_code": "18960-1512", "report_date": "20130904", "product_type": "Drugs", "recall_number": "D-924-2013", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA, Inc.", "product_quantity": "9003 Bottles", "termination_date": "20140827", "reason_for_recall": "Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03", "distribution_pattern": "Nationwide", "recall_initiation_date": "20130806", "initial_firm_notification": "Letter", "center_classification_date": "20130827"} 2026-07-08 15:18:37.097746-07
+mrcl_01kx1wzh20whnwhwxeq539w153 user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-851-2013 Class II Terminated Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045. 2013-05-20 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-851-2013 {"city": "Lake Forest", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {"unii": ["NMH84OZK2B"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["283504", "1740467"], "spl_id": ["aeec44c2-fd88-48cc-ad91-599688f5319f"], "brand_name": ["ONDANSETRON"], "spl_set_id": ["6a11f61b-2318-4382-2b91-4366e4bb53fa"], "package_ndc": ["0409-4755-18", "0409-4755-03", "0409-4759-01"], "product_ndc": ["0409-4755", "0409-4759"], "generic_name": ["ONDANSETRON"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ONDANSETRON HYDROCHLORIDE"], "manufacturer_name": ["Hospira, Inc."], "application_number": ["ANDA077548"], "is_original_packager": [true]}, "event_id": "65300", "address_1": "600 N Field Dr Bldg J45", "address_2": "N/A", "code_info": "Lot 25394DK, exp. 01/2015", "postal_code": "60045", "report_date": "20130814", "product_type": "Drugs", "recall_number": "D-851-2013", "classification": "Class II", "recalling_firm": "Hospira, Inc.", "product_quantity": "340,600 vials", "termination_date": "20141028", "reason_for_recall": "Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20130520", "initial_firm_notification": "Letter", "center_classification_date": "20130807"} 2026-07-08 15:18:37.504177-07
+mrcl_01kx1wzh21gvek5xtvg3qfvhvc user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-1691-2019 Class II Terminated Lack of Assurance of Sterility ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0158-02 2019-06-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1691-2019 {"city": "Athens", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "83074", "address_1": "340 W State St Unit 9", "address_2": "N/A", "code_info": "All lots within expiry", "postal_code": "45701-1564", "report_date": "20190814", "product_type": "Drugs", "recall_number": "D-1691-2019", "classification": "Class II", "recalling_firm": "RXQ Compounding LLC", "product_quantity": "N/A", "termination_date": "20220916", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0158-02", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20190619", "initial_firm_notification": "Press Release", "center_classification_date": "20190808"} 2026-07-08 15:18:37.505361-07
+mrcl_01kx1wzh21y1wrq8atay74tj6n user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-0246-2026 Class II Ongoing Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 2025-12-30 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2026 {"city": "Elmwood Park", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0368462157138", "0368462106303", "0368462105306", "0368462158111"], "unii": ["4AF302ESOS", "NMH84OZK2B"], "route": ["ORAL"], "rxcui": ["104894", "198052", "312086", "312087"], "spl_id": ["32177a6a-8c35-4e1c-b7f5-7376b1c1316a"], "brand_name": ["ONDANSETRON"], "spl_set_id": ["eee5217a-eba8-463a-812d-bf3c66f0934f"], "package_ndc": ["68462-105-33", "68462-105-30", "68462-106-33", "68462-106-30", "68462-157-13", "68462-158-11", "68462-158-13"], "product_ndc": ["68462-105", "68462-106", "68462-157", "68462-158"], "generic_name": ["ONDANSETRON"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ONDANSETRON HYDROCHLORIDE"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA077535"], "is_original_packager": [true]}, "event_id": "98233", "address_1": "619 River Dr", "address_2": "N/A", "code_info": "Lot #: 19251311, Exp Date April 2027", "postal_code": "07407-1317", "report_date": "20260107", "product_type": "Drugs", "recall_number": "D-0246-2026", "classification": "Class II", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "product_quantity": "96,948 packs", "reason_for_recall": "Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13", "distribution_pattern": "Nationwide within the United States", "recall_initiation_date": "20251230", "initial_firm_notification": "Letter", "center_classification_date": "20251231"} 2026-07-08 15:18:37.505934-07
+mrcl_01kx1wzh22rdr1d9z867fbdps1 user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-0440-2021 Class II Terminated CGMP Deviations: Intermittent exposure to temperature excursion during storage. ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS 2021-03-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0440-2021 {"city": "Dublin", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "87512", "address_1": "7000 Cardinal Pl", "address_2": "N/A", "code_info": "ON0420015-A", "postal_code": "43017-1091", "report_date": "20210602", "product_type": "Drugs", "recall_number": "D-0440-2021", "classification": "Class II", "recalling_firm": "Cardinal Health Inc.", "product_quantity": "1935 bottles", "termination_date": "20240617", "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS", "distribution_pattern": "FL, GA, SC", "recall_initiation_date": "20210315", "initial_firm_notification": "Letter", "center_classification_date": "20210524"} 2026-07-08 15:18:37.50686-07
+mrcl_01kx1wzh23b20a3p11g1x83pwb user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-013-2014 Class II Terminated Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03 2013-09-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-013-2014 {"city": "Lake Forest", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {"upc": ["040947550329"], "unii": ["NMH84OZK2B"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["283504", "1740467"], "spl_id": ["aeec44c2-fd88-48cc-ad91-599688f5319f"], "brand_name": ["ONDANSETRON"], "spl_set_id": ["6a11f61b-2318-4382-2b91-4366e4bb53fa"], "package_ndc": ["0409-4755-18", "0409-4755-03", "0409-4759-01"], "product_ndc": ["0409-4755", "0409-4759"], "generic_name": ["ONDANSETRON"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ONDANSETRON HYDROCHLORIDE"], "manufacturer_name": ["Hospira, Inc."], "application_number": ["ANDA077548"], "is_original_packager": [true]}, "event_id": "66422", "address_1": "275 N Field Dr", "address_2": "", "code_info": "29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)", "postal_code": "60045-2579", "report_date": "20131127", "product_type": "Drugs", "recall_number": "D-013-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Hospira Inc.", "product_quantity": "681,400 vials", "termination_date": "20141006", "reason_for_recall": "Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20130924", "initial_firm_notification": "Letter", "center_classification_date": "20131120"} 2026-07-08 15:18:37.50742-07
+mrcl_01kx1wzh243q5b07d3t5tb74v8 user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-825-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Ondansetron HCl Dihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-825-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-825-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "2035 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ondansetron HCl Dihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:37.508216-07
+mrcl_01kx1wzh2532esxr00sbrwn414 user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-0841-2016 Class II Terminated Failed Impurities/Degradation Specifications; 12 month stability time point Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30 2016-03-30 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0841-2016 {"city": "Princeton", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "73822", "address_1": "107 College Rd E", "address_2": "N/A", "code_info": "Lot number C500691, exp 12/2016", "postal_code": "08540-6623", "report_date": "20160518", "product_type": "Drugs", "recall_number": "D-0841-2016", "classification": "Class II", "recalling_firm": "Dr. Reddy's Laboratories, Inc.", "product_quantity": "50,280 bottles", "termination_date": "20170410", "reason_for_recall": "Failed Impurities/Degradation Specifications; 12 month stability time point", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30", "distribution_pattern": "Nationwide", "recall_initiation_date": "20160330", "initial_firm_notification": "Letter", "center_classification_date": "20160509"} 2026-07-08 15:18:37.509489-07
+mrcl_01kx1wzh26bea76cnp95b1ys45 user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-0312-2023 Class II Terminated Lack of sterility assurance ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 2022-12-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0312-2023 {"city": "Chesapeake", "state": "VA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "91466", "address_1": "535 Independence Pkwy Ste 300", "address_2": "N/A", "code_info": "Beyond Use Date: December 29-30, 2022", "postal_code": "23320-5176", "report_date": "20230222", "product_type": "Drugs", "recall_number": "D-0312-2023", "classification": "Class II", "recalling_firm": "Sentara Infusion Services", "product_quantity": "15 bags", "termination_date": "20260220", "reason_for_recall": "Lack of sterility assurance", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320", "distribution_pattern": "Dispensed to Patients Nationwide.", "recall_initiation_date": "20221227", "initial_firm_notification": "Telephone", "center_classification_date": "20230215"} 2026-07-08 15:18:37.510097-07
+mrcl_01kx1wzh268wm0tva2mr50qdj5 user_steve med_01kx1wz68v8p24drx8rtk0qs7m openFDA D-0239-2026 Class II Ongoing Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01 2025-11-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0239-2026 {"city": "Anaheim", "state": "CA", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "98141", "address_1": "1250 N Lakeview Ave Ste O", "address_2": "", "code_info": "Lot: J1325J, I1725P, EXP Date: 4/30/2027.", "postal_code": "92807-1801", "report_date": "20251224", "product_type": "Drugs", "recall_number": "D-0239-2026", "classification": "Class II", "more_code_info": "", "recalling_firm": "Preferred Pharmaceuticals, Inc.", "product_quantity": "575 1x10 Foil Blister Packs", "reason_for_recall": "Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01", "distribution_pattern": "Natinowide in the USA", "recall_initiation_date": "20251117", "initial_firm_notification": "Letter", "center_classification_date": "20251217"} 2026-07-08 15:18:37.51083-07
+mrcl_01kx1wzhe1v3sfja846je2rvpk user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0644-2017 Class I Terminated Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40 2017-02-03 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0644-2017 {"city": "Little Rock", "state": "AR", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "76395", "address_1": "8821 Knoedl Ct", "address_2": "N/A", "code_info": "Lot: 20161222@8, Exp 2/5/2017", "postal_code": "72205-4600", "report_date": "20170412", "product_type": "Drugs", "recall_number": "D-0644-2017", "classification": "Class I", "recalling_firm": "SCA Pharmaceuticals", "product_quantity": "30 bags", "termination_date": "20171019", "reason_for_recall": "Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40", "distribution_pattern": "U.S. Nationwide", "recall_initiation_date": "20170203", "initial_firm_notification": "Letter", "center_classification_date": "20170405"} 2026-07-08 15:18:37.889768-07
+mrcl_01kx1wzhe2dskz4ftn32zfbeg5 user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0323-2023 Class II Terminated Lack of sterility assurance VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 2022-12-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0323-2023 {"city": "Chesapeake", "state": "VA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "91466", "address_1": "535 Independence Pkwy Ste 300", "address_2": "N/A", "code_info": "Beyond Use Date: December 28-31, 2022", "postal_code": "23320-5176", "report_date": "20230222", "product_type": "Drugs", "recall_number": "D-0323-2023", "classification": "Class II", "recalling_firm": "Sentara Infusion Services", "product_quantity": "18 bags", "termination_date": "20260220", "reason_for_recall": "Lack of sterility assurance", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320", "distribution_pattern": "Dispensed to Patients Nationwide.", "recall_initiation_date": "20221227", "initial_firm_notification": "Telephone", "center_classification_date": "20230215"} 2026-07-08 15:18:37.890629-07
+mrcl_01kx1wzhe39atqegkwzcwstb4k user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0641-2017 Class I Terminated Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59 2017-02-03 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2017 {"city": "Little Rock", "state": "AR", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "76395", "address_1": "8821 Knoedl Ct", "address_2": "N/A", "code_info": "Lot: 20161213@23, Exp 2/11/2017; Lot: 20161214@80, Exp 2/12/2017; Lot: 20161215@1, Exp 2/13/2017", "postal_code": "72205-4600", "report_date": "20170412", "product_type": "Drugs", "recall_number": "D-0641-2017", "classification": "Class I", "recalling_firm": "SCA Pharmaceuticals", "product_quantity": "716 bags", "termination_date": "20171019", "reason_for_recall": "Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59", "distribution_pattern": "U.S. Nationwide", "recall_initiation_date": "20170203", "initial_firm_notification": "Letter", "center_classification_date": "20170405"} 2026-07-08 15:18:37.891189-07
+mrcl_01kx1wzhe3298nppn5r71b64sm user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0071-2024 Class III Terminated Labeling: Not Elsewhere Classified VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68. 2023-10-04 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0071-2024 {"city": "Englewood", "state": "CO", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "93178", "address_1": "13796 Compark Blvd", "address_2": "N/A", "code_info": "Lot#: 2330781, Exp. 10/19/23; 2330791, Exp. 10/29/23; 2330795, Exp. 11/02/23; 2330800, Exp. 11/09/23; 2330807, Exp. 11/11/23; 2330812, Exp. 11/16/23; 2330816, Exp. 11/19/23; 2330822, 10/20/23; 2330897,11/23/23; 2330899, 11/25/23; 2330901, 11/26/23; 2330918, 11/30/23; 2330943, 01/12/24; 2331050, 01/14/24; 2331064, 01/21/24; 2331102, Exp. 01/25/24.", "postal_code": "80112-7145", "report_date": "20231101", "product_type": "Drugs", "recall_number": "D-0071-2024", "classification": "Class III", "recalling_firm": "Denver Solutions, LLC DBA Leiters Health", "product_quantity": "33,480 IV Bags", "termination_date": "20240815", "reason_for_recall": "Labeling: Not Elsewhere Classified", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20231004", "initial_firm_notification": "Letter", "center_classification_date": "20231026"} 2026-07-08 15:18:37.891816-07
+mrcl_01kx1wzhe4yf6zzvn38er1cs9f user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-1387-2015 Class II Terminated Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. 2015-06-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1387-2015 {"city": "Chatham", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "71591", "address_1": "195 Main St", "address_2": "N/A", "code_info": "Lot #: a) 06042015@15, Exp 06/18/15; 06052015@3, Exp 06/19/15; b) 06082015@21, Exp 06/22/15", "postal_code": "07928-2405", "report_date": "20150902", "product_type": "Drugs", "recall_number": "D-1387-2015", "classification": "Class II", "recalling_firm": "Liberty Drug & Surgical", "product_quantity": "3 bottles", "termination_date": "20180423", "reason_for_recall": "Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.", "distribution_pattern": "Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY", "recall_initiation_date": "20150615", "initial_firm_notification": "Telephone", "center_classification_date": "20150827"} 2026-07-08 15:18:37.89273-07
+mrcl_01kx1wzhe5w85x56srd66f3e3a user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0968-2023 Class II Terminated Lack of assurance of sterility. Validation data for decontamination cycles is lacking. vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1 2023-07-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0968-2023 {"city": "Phoenix", "state": "AZ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "92707", "address_1": "2200 S 43rd Ave", "address_2": "N/A", "code_info": "Lot: 36-239516, 36-239517, Exp. 7/12/2023; 36-239989, Exp. 7/13/2023; 36-240798, Exp. 7/17/2023; 36-241133, Exp. 7/19/2023; 36-241981, Exp. 7/24/2023; 36-242717, Exp. 7/26/2023; 36-245577, Exp. 8/2/2023.", "postal_code": "85043-3909", "report_date": "20230809", "product_type": "Drugs", "recall_number": "D-0968-2023", "classification": "Class II", "recalling_firm": "Central Admixture Pharmacy Services, Inc.", "product_quantity": "2,914 bags", "termination_date": "20250328", "reason_for_recall": "Lack of assurance of sterility. Validation data for decontamination cycles is lacking.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20230714", "initial_firm_notification": "Letter", "center_classification_date": "20230801"} 2026-07-08 15:18:37.893574-07
+mrcl_01kx1wzhsy0qxqg621fbrwcmcr user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-1517-2019 Class II Terminated Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. 2019-07-11 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1517-2019 {"city": "Monmouth Junction", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0327808086013"], "unii": ["V1Q0O9OJ9Z", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["1087459"], "spl_id": ["b3ac95d4-bef9-4e32-9822-73b9534c9869"], "brand_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "spl_set_id": ["25f400d9-1d6e-4d38-8f0d-98d471eba73b"], "package_ndc": ["27808-086-02", "27808-086-01", "27808-086-03"], "product_ndc": ["27808-086"], "generic_name": ["HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["CHLORPHENIRAMINE MALEATE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "application_number": ["ANDA091632"], "is_original_packager": [true]}, "event_id": "83346", "address_1": "2033 US Highway 130", "address_2": "N/A", "code_info": "Lot#: 14079, Exp 10/2021", "postal_code": "08852-3003", "report_date": "20190731", "product_type": "Drugs", "recall_number": "D-1517-2019", "classification": "Class II", "recalling_firm": "Tris Pharma Inc.", "product_quantity": "2,550 bottles", "termination_date": "20211102", "reason_for_recall": "Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20190711", "initial_firm_notification": "Letter", "center_classification_date": "20190724"} 2026-07-08 15:18:38.270749-07
+mrcl_01kx1wzhe5nm9vmcnt02tmz7s0 user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0792-2016 Class II Terminated Lack of Assurance of Sterility Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78 2016-02-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0792-2016 {"city": "Allentown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "73336", "address_1": "401 N 17th St", "address_2": "N/A", "code_info": "Lot #: 012216, 012616, 012816, 020316, 020616;", "postal_code": "18104-5034", "report_date": "20160406", "product_type": "Drugs", "recall_number": "D-0792-2016", "classification": "Class II", "recalling_firm": "Walter's Pharmacy", "product_quantity": "4 bottles", "termination_date": "20170106", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78", "distribution_pattern": "PA", "recall_initiation_date": "20160212", "initial_firm_notification": "Telephone", "center_classification_date": "20160329"} 2026-07-08 15:18:37.894123-07
+mrcl_01kx1wzhe6f6tkavfw6tbwr4fs user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0647-2023 Class II Ongoing Lack of Assurance of Sterility VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25 2023-05-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2023 {"city": "Columbia", "state": "MO", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "92348", "address_1": "3801 Mojave Ct Ste 101", "address_2": "N/A", "code_info": "Lot #: AC-016633, Exp. Date 05/24/2023; AC-016651, Exp. Date 07/22/2023", "postal_code": "65202-4042", "report_date": "20230524", "product_type": "Drugs", "recall_number": "D-0647-2023", "classification": "Class II", "recalling_firm": "Apollo Care, LLC", "product_quantity": "646 bags", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25", "distribution_pattern": "Missouri only", "recall_initiation_date": "20230502", "initial_firm_notification": "Letter", "center_classification_date": "20230518"} 2026-07-08 15:18:37.894631-07
+mrcl_01kx1wzhe73b75895vct11refd user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-0929-2023 Class II Terminated CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50; 2023-07-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0929-2023 {"city": "Woburn", "state": "MA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "92690", "address_1": "4 Constitution Way Ste L", "address_2": "N/A", "code_info": "Lot # 20230524-0113AB, Exp 22AUG2023", "postal_code": "01801-1042", "report_date": "20230726", "product_type": "Drugs", "recall_number": "D-0929-2023", "classification": "Class II", "more_code_info": "", "recalling_firm": "New England Life Care, Inc. dba Advanced Compounding Solutions", "product_quantity": "209 Bags", "termination_date": "20231204", "reason_for_recall": "CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20230710", "initial_firm_notification": "Letter", "center_classification_date": "20230719"} 2026-07-08 15:18:37.8952-07
+mrcl_01kx1wzhe7c2zmq08de83vqvws user_steve med_01kx1wz68vng2gg8a6ya49hsqh openFDA D-680-2013 Class II Terminated Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 2013-03-20 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-680-2013 {"city": "Augusta", "state": "GA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "64661", "address_1": "318 Baston Rd", "address_2": "N/A", "code_info": "Lot number CABDCCAC:54, Exp date: 3/24/2013.", "postal_code": "30907", "report_date": "20130710", "product_type": "Drugs", "recall_number": "D-680-2013", "classification": "Class II", "recalling_firm": "Clinical Specialties Compounding Pharmacy", "product_quantity": "20ml total", "termination_date": "20170222", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907", "distribution_pattern": "FL, GA and SC.", "recall_initiation_date": "20130320", "initial_firm_notification": "Telephone", "center_classification_date": "20130703"} 2026-07-08 15:18:37.895797-07
+mrcl_01kx1wzhstbmvpfcctrd2ee0dt user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-058-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. 2012-09-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-058-2013 {"city": "Corona", "state": "CA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63246", "address_1": "311 Bonnie Cir", "address_2": "N/A", "code_info": "Lot #: 519406A, 521759A, Exp 04/14", "postal_code": "92880-2882", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-058-2013", "classification": "Class I", "recalling_firm": "Watson Laboratories Inc", "product_quantity": "4,874 bottles", "termination_date": "20140324", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20120921", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:38.266752-07
+mrcl_01kx1wzhsv0z7pkgmwsabnxkba user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-0599-2018 Class III Terminated Failed Impurities/Degradation Specifications Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038 2018-03-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2018 {"city": "Somerset", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0343386118038", "343386118038"], "unii": ["68JRS2HC1C", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["992656"], "spl_id": ["116df522-26b7-42de-8c0b-16cc60c2e764"], "brand_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "spl_set_id": ["41ac90b3-f007-4eb2-9d41-ea626ced2017"], "package_ndc": ["43386-118-03", "43386-118-01", "43386-118-05", "3433861180"], "product_ndc": ["43386-118"], "generic_name": ["HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["HOMATROPINE METHYLBROMIDE", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "application_number": ["ANDA091528"], "is_original_packager": [true]}, "event_id": "79298", "address_1": "400 Campus Dr", "address_2": "", "code_info": "M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);", "postal_code": "08873-1145", "report_date": "20180321", "product_type": "Drugs", "recall_number": "D-0599-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Novel Laboratories, Inc.", "product_quantity": "134,364 bottles (4,030,920 tablets)", "termination_date": "20200608", "reason_for_recall": "Failed Impurities/Degradation Specifications", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038", "distribution_pattern": "Nationwide", "recall_initiation_date": "20180305", "initial_firm_notification": "Letter", "center_classification_date": "20180314"} 2026-07-08 15:18:38.267411-07
+mrcl_01kx1wzhsvkxf396rhdhfy3jp4 user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-0276-2022 Class II Terminated Product Mix-up Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01. 2021-11-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0276-2022 {"city": "Central Islip", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0331722997010", "0331722996013"], "unii": ["362O9ITL9D", "NO70W886KK"], "route": ["ORAL"], "rxcui": ["856999", "857002"], "spl_id": ["d745e0ac-ee48-44c7-8430-8da0a69d2735"], "brand_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "spl_set_id": ["ed6af366-753c-4f3b-a6a2-c9a183c50035"], "package_ndc": ["31722-996-01", "31722-996-05", "31722-997-01", "31722-997-05"], "product_ndc": ["31722-996", "31722-997"], "generic_name": ["HYDROCODONE BITARTRATE AND ACETAMINOPHEN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ACETAMINOPHEN", "HYDROCODONE BITARTRATE"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "application_number": ["ANDA211487"], "is_original_packager": [true]}, "event_id": "89060", "address_1": "400 S Technology Dr", "address_2": "N/A", "code_info": "Lot #: 21070817, Exp 6/2023", "postal_code": "11722-4402", "report_date": "20211215", "product_type": "Drugs", "recall_number": "D-0276-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Ascent Pharmaceuticals, Inc.", "product_quantity": "9744 bottles", "termination_date": "20231206", "reason_for_recall": "Product Mix-up", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20211119", "initial_firm_notification": "Letter", "center_classification_date": "20211207"} 2026-07-08 15:18:38.267986-07
+mrcl_01kx1wzhswdf4ckhpshvt62e4a user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-1383-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1383-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18B013, Exp. 02/2020; 18E024; 18E030, Exp. 05/2020.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1383-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "11,112 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:38.268683-07
+mrcl_01kx1wzhsx20j64b0j7qsb7fwq user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-138-2013 Class I Terminated Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. 2012-12-06 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-138-2013 {"city": "Huntsville", "state": "AL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "63818", "address_1": "120 Vintage Dr NE", "address_2": "", "code_info": "Lot #: All that begin with the letter \\"C\\" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20130206", "product_type": "Drugs", "recall_number": "D-138-2013", "classification": "Class I", "more_code_info": "", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "897,379 bottles", "termination_date": "20210720", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20121206", "initial_firm_notification": "Press Release", "center_classification_date": "20130130"} 2026-07-08 15:18:38.26913-07
+mrcl_01kx1wzhsx7st229hx2e7c73xf user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-1384-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1384-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 18E034, Exp. 05/2020; 19A015, Exp. 01/2021.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1384-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "7,728 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:38.26962-07
+mrcl_01kx1wzhsxxpeeqatt4ffy3w62 user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-057-2013 Class I Ongoing Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 2012-09-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-057-2013 {"city": "Huntsville", "state": "AL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "63138", "address_1": "120 Vintage Dr NE", "address_2": "N/A", "code_info": "Lot number: C1440512A, Exp 12/13", "postal_code": "35811-8216", "report_date": "20121128", "product_type": "Drugs", "recall_number": "D-057-2013", "classification": "Class I", "recalling_firm": "Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals", "product_quantity": "14,445 bottles", "reason_for_recall": "Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21", "distribution_pattern": "Nationwide.", "recall_initiation_date": "20120910", "initial_firm_notification": "Press Release", "center_classification_date": "20121116"} 2026-07-08 15:18:38.270021-07
+mrcl_01kx1wzhszeqwp1fpvf4hcfkgg user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-609-2014 Class II Terminated Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014. HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-609-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg has the following code Pedigree: W004005, EXP: 7/1/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-609-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:38.271268-07
+mrcl_01kx1wzhsz0k7ntykxbb07kp38 user_steve med_01kx1wz68wgp6931cm84fbsh9n openFDA D-1139-2017 Class III Terminated Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16 2017-08-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1139-2017 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "77998", "address_1": "7265 Ulmerton Rd", "address_2": "N/A", "code_info": "Lot: 494700 Exp. 10/2018", "postal_code": "33771-4809", "report_date": "20170920", "product_type": "Drugs", "recall_number": "D-1139-2017", "classification": "Class III", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "3084 bottles", "termination_date": "20190311", "reason_for_recall": "Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16", "distribution_pattern": "Nationwide", "recall_initiation_date": "20170817", "initial_firm_notification": "Letter", "center_classification_date": "20170912"} 2026-07-08 15:18:38.271862-07
+mrcl_01kx1wzj9ekbe1r4j23nncdgvh user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-0971-2015 Class II Terminated Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960 2015-04-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0971-2015 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "70976", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015.", "postal_code": "19044-1220", "report_date": "20150506", "product_type": "Drugs", "recall_number": "D-0971-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "", "termination_date": "20161027", "reason_for_recall": "Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150413", "initial_firm_notification": "Letter", "center_classification_date": "20150427"} 2026-07-08 15:18:38.766888-07
+mrcl_01kx1wzj9fz0r737qj434petsk user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-0456-2025 Class II Completed CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) 2025-05-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0456-2025 {"city": "Basking Ridge", "state": "NJ", "status": "Completed", "country": "United States", "openfda": {"upc": ["0313668443301", "0313668473308"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["2532159", "2532163"], "spl_id": ["f8d8c930-c8f9-4186-92fa-6f7a5dabe083"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74"], "package_ndc": ["13668-443-74", "13668-443-10", "13668-443-01", "13668-443-30", "13668-443-91", "13668-473-10", "13668-473-74", "13668-473-30", "13668-473-01", "13668-473-91", "13668-473-70"], "product_ndc": ["13668-443", "13668-473"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "application_number": ["ANDA206937"], "is_original_packager": [true]}, "event_id": "96983", "address_1": "106 Allen Rd Ste 305", "address_2": "N/A", "code_info": "Lot# BDX6K001; Exp. Date: 06/30/2025", "postal_code": "07920-3851", "report_date": "20250611", "product_type": "Drugs", "recall_number": "D-0456-2025", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc.", "product_quantity": "972 Cartons", "reason_for_recall": "CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)", "distribution_pattern": "U.S. Nationwide.", "recall_initiation_date": "20250527", "initial_firm_notification": "E-Mail", "center_classification_date": "20250602"} 2026-07-08 15:18:38.767966-07
+mrcl_01kx1wzj9gp10009hat9xy75hd user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-0291-2015 Class III Terminated Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule. Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01 2014-12-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0291-2015 {"city": "Broomfield", "state": "CO", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "69942", "address_1": "2555 W Midway Blvd", "address_2": "N/A", "code_info": "Lot ET5122, Exp. 10/17", "postal_code": "80020-1632", "report_date": "20141217", "product_type": "Drugs", "recall_number": "D-0291-2015", "classification": "Class III", "recalling_firm": "Sandoz Incorporated", "product_quantity": "1,008 bottles", "termination_date": "20150624", "reason_for_recall": "Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01", "distribution_pattern": "AZ", "recall_initiation_date": "20141205", "initial_firm_notification": "Letter", "center_classification_date": "20141209"} 2026-07-08 15:18:38.768816-07
+mrcl_01kx1wzj9hzv5a48041xapkdnh user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-1280-2014 Class II Terminated Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. 2014-02-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1280-2014 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "67563", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15", "postal_code": "19044-1220", "report_date": "20140507", "product_type": "Drugs", "recall_number": "D-1280-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "257904 bottles", "termination_date": "20141215", "reason_for_recall": "Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20140212", "initial_firm_notification": "Letter", "center_classification_date": "20140428"} 2026-07-08 15:18:38.769397-07
+mrcl_01kx1wzj9j92d0gq9kgwr9s8ye user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-0578-2018 Class III Terminated Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities. Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56 2018-02-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0578-2018 {"city": "North Wales", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79118", "address_1": "1090 Horsham Rd", "address_2": "", "code_info": "All lots within expiry.", "postal_code": "19454-1505", "report_date": "20180221", "product_type": "Drugs", "recall_number": "D-0578-2018", "classification": "Class III", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "1,157,095 bottles", "termination_date": "20190430", "reason_for_recall": "Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56", "distribution_pattern": "Distributed throughout the United States", "recall_initiation_date": "20180205", "initial_firm_notification": "Letter", "center_classification_date": "20180305"} 2026-07-08 15:18:38.770508-07
+mrcl_01kx1wzj9kb1c0s7pqrpbqxe99 user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-1281-2014 Class II Terminated Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5. 2014-02-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2014 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"upc": ["350111647015"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "67563", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15", "postal_code": "19044-1220", "report_date": "20140507", "product_type": "Drugs", "recall_number": "D-1281-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "72,356 bottles", "termination_date": "20141215", "reason_for_recall": "Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20140212", "initial_firm_notification": "Letter", "center_classification_date": "20140428"} 2026-07-08 15:18:38.772087-07
+mrcl_01kx1wzj9mg1qc1b439xkhrwj8 user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-1279-2014 Class II Terminated Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor. Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. 2014-02-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1279-2014 {"city": "Earth City", "state": "MO", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0368645130545", "368645130545"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["4c222d2c-813c-5520-e063-6294a90affe6"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["b07f9eab-44ac-4667-bd46-52d736daa5d6"], "package_ndc": ["68645-131-54", "68645-130-54"], "product_ndc": ["68645-130", "68645-131"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"], "application_number": ["ANDA076001"], "original_packager_product_ndc": ["50111-647", "50111-648"]}, "event_id": "67526", "address_1": "13333 Lakefront Dr", "address_2": "", "code_info": "Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15", "postal_code": "63045-1514", "report_date": "20140507", "product_type": "Drugs", "recall_number": "D-1279-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Legacy Pharmaceutical Packaging", "product_quantity": "667,068 bottles", "termination_date": "20171127", "reason_for_recall": "Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20140214", "initial_firm_notification": "Telephone", "center_classification_date": "20140428"} 2026-07-08 15:18:38.772519-07
+mrcl_01kx1wzj9myjn1eneqckdg3315 user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-517-2014 Class II Terminated Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014. FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-517-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "FLUoxetine HCl, Capsule, 10 mg has the following code Pedigree: AD70585_13, EXP: 5/29/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-517-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "100 Capsules", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:38.773129-07
+mrcl_01kx1wzj9nqy4d551bgg8tarh3 user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-0970-2015 Class II Terminated Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01 2015-04-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0970-2015 {"city": "Horsham", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {"unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["310384", "310385"], "spl_id": ["424ed364-e023-472f-b113-673e9342a7f1"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["06d71a33-5578-4012-b11d-764f45bc1e6a"], "package_ndc": ["50111-647-01", "50111-647-02", "50111-647-03", "50111-648-01", "50111-648-02", "50111-648-03", "50111-648-44"], "product_ndc": ["50111-647", "50111-648"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA076001"], "is_original_packager": [true]}, "event_id": "70976", "address_1": "425 Privet Rd", "address_2": "", "code_info": "Lot #: 6A207012, Exp 7/2015.", "postal_code": "19044-1220", "report_date": "20150506", "product_type": "Drugs", "recall_number": "D-0970-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "", "termination_date": "20161027", "reason_for_recall": "Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150413", "initial_firm_notification": "Letter", "center_classification_date": "20150427"} 2026-07-08 15:18:38.773707-07
+mrcl_01kx1wzj9pgyxepwgekpyvg32j user_steve med_01kx1wz68wdjveg0vtsw6pwk3d openFDA D-0455-2025 Class II Completed CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 2025-05-27 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0455-2025 {"city": "Basking Ridge", "state": "NJ", "status": "Completed", "country": "United States", "openfda": {"upc": ["0313668443301", "0313668473308"], "unii": ["I9W7N6B1KJ"], "route": ["ORAL"], "rxcui": ["2532159", "2532163"], "spl_id": ["f8d8c930-c8f9-4186-92fa-6f7a5dabe083"], "brand_name": ["FLUOXETINE"], "spl_set_id": ["dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74"], "package_ndc": ["13668-443-74", "13668-443-10", "13668-443-01", "13668-443-30", "13668-443-91", "13668-473-10", "13668-473-74", "13668-473-30", "13668-473-01", "13668-473-91"], "product_ndc": ["13668-443", "13668-473"], "generic_name": ["FLUOXETINE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["FLUOXETINE HYDROCHLORIDE"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "application_number": ["ANDA206937"], "is_original_packager": [true]}, "event_id": "96983", "address_1": "106 Allen Rd Ste 305", "address_2": "N/A", "code_info": "Lot# BDX6K001; Exp. Date 06/30/2025", "postal_code": "07920-3851", "report_date": "20250611", "product_type": "Drugs", "recall_number": "D-0455-2025", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc.", "product_quantity": "3672 Bottles", "reason_for_recall": "CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30", "distribution_pattern": "U.S. Nationwide.", "recall_initiation_date": "20250527", "initial_firm_notification": "E-Mail", "center_classification_date": "20250602"} 2026-07-08 15:18:38.77428-07
+mrcl_01kx1wzjpay9t6y3y145nkn4ec user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-1669-2012 Class III Terminated Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50," METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771 2011-01-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1669-2012 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "62887", "address_1": "7265 Ulmerton Rd", "address_2": "N/A", "code_info": "195900 exp. 01/12.", "postal_code": "33771-4809", "report_date": "20120905", "product_type": "Drugs", "recall_number": "D-1669-2012", "classification": "Class III", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "73,800 cups", "termination_date": "20120830", "reason_for_recall": "Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed \\"5 mL x 50,\\" instead of \\"10 mL x 50,\\"", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771", "distribution_pattern": "Nationwide", "recall_initiation_date": "20110119", "initial_firm_notification": "Letter", "center_classification_date": "20120829"} 2026-07-08 15:18:39.178854-07
+mrcl_01kx1wzjpb4shamrczen92064h user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-0473-2025 Class II Ongoing Presence of foreign tablets/capsules. Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01. 2025-05-23 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0473-2025 {"city": "Parsippany", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"upc": ["0300932203013", "0300932204010"], "unii": ["W1792A2RVD"], "route": ["ORAL"], "rxcui": ["311666", "311668"], "spl_id": ["61b5d2d5-1e7b-44ff-a831-1a0de78edecd"], "brand_name": ["METOCLOPRAMIDE"], "spl_set_id": ["e15905e0-e0f6-4c8b-ac19-59724d6c4bf0"], "package_ndc": ["0093-2204-01", "0093-2204-05", "0093-2203-01", "0093-2203-05", "0093-2203-10"], "product_ndc": ["0093-2203", "0093-2204"], "generic_name": ["METOCLOPRAMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METOCLOPRAMIDE HYDROCHLORIDE"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "application_number": ["ANDA070184"], "is_original_packager": [true]}, "event_id": "96919", "address_1": "400 Interpace Pkwy Bldg A", "address_2": "", "code_info": "Lot#: 5420094, Exp 09/30/2027", "postal_code": "07054-1120", "report_date": "20250702", "product_type": "Drugs", "recall_number": "D-0473-2025", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA, Inc", "product_quantity": "36612 cartons", "reason_for_recall": "Presence of foreign tablets/capsules.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.", "distribution_pattern": "USA Nationwide", "recall_initiation_date": "20250523", "initial_firm_notification": "Letter", "center_classification_date": "20250620"} 2026-07-08 15:18:39.179871-07
+mrcl_01kx1wzjpc18bh2q9zgyadesy3 user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-0277-2021 Class II Terminated Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618. 2021-02-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0277-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"unii": ["W1792A2RVD"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["311670"], "spl_id": ["e4deb814-efe2-4ed2-84e6-fc9cde89d9e5"], "brand_name": ["METOCLOPRAMIDE"], "spl_set_id": ["cccf04bd-7463-40b8-a41f-cb1093c358d7"], "package_ndc": ["0703-4502-01", "0703-4502-04"], "product_ndc": ["0703-4502"], "generic_name": ["METOCLOPRAMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METOCLOPRAMIDE HYDROCHLORIDE"], "manufacturer_name": ["Teva Parenteral Medicines, Inc."], "application_number": ["ANDA073135"], "is_original_packager": [true]}, "event_id": "87298", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "Lot # 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. date 11/2021 31326230B, exp. date 12/2021 31323816B, exp. date 02/2021", "postal_code": "07054-1120", "report_date": "20210303", "product_type": "Drugs", "recall_number": "D-0277-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "29,357 vials", "termination_date": "20240515", "reason_for_recall": "Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.", "distribution_pattern": "Product was distributed nationwide in the USA and Puerto Rico.", "recall_initiation_date": "20210210", "initial_firm_notification": "Letter", "center_classification_date": "20210221"} 2026-07-08 15:18:39.180539-07
+mrcl_01kx1wzjpdap44y7521x412ch9 user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-0459-2017 Class II Terminated CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50. 2017-01-18 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0459-2017 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "75650", "address_1": "7265 Ulmerton Rd", "address_2": "N/A", "code_info": "Lot No. 428700 (Exp. 11/17), 409500 (Exp.06/17)", "postal_code": "33771-4809", "report_date": "20170208", "product_type": "Drugs", "recall_number": "D-0459-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "3,496 unit dose cups", "termination_date": "20210826", "reason_for_recall": "CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20170118", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20170202"} 2026-07-08 15:18:39.181157-07
+mrcl_01kx1wzjpdg2ndqkz57h4k0ej8 user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-0377-2021 Class II Terminated Lack of Assurance of Sterility Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04 2021-04-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0377-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"unii": ["W1792A2RVD"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["311670"], "spl_id": ["e4deb814-efe2-4ed2-84e6-fc9cde89d9e5"], "brand_name": ["METOCLOPRAMIDE"], "spl_set_id": ["cccf04bd-7463-40b8-a41f-cb1093c358d7"], "package_ndc": ["0703-4502-01", "0703-4502-04"], "product_ndc": ["0703-4502"], "generic_name": ["METOCLOPRAMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METOCLOPRAMIDE HYDROCHLORIDE"], "manufacturer_name": ["Teva Parenteral Medicines, Inc."], "application_number": ["ANDA073135"], "is_original_packager": [true]}, "event_id": "87875", "address_1": "400 Interpace Pkwy", "address_2": "N/A", "code_info": "Lot # 31325459B, exp. date 08/2021", "postal_code": "07054-1120", "report_date": "20210526", "product_type": "Drugs", "recall_number": "D-0377-2021", "classification": "Class II", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "3,138/25 single use vials per tray", "termination_date": "20240604", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04", "distribution_pattern": "Product was distributed nationwide.", "recall_initiation_date": "20210426", "initial_firm_notification": "Letter", "center_classification_date": "20210514"} 2026-07-08 15:18:39.1815-07
+mrcl_01kx1wzjpdkywanqypgvkb5kfj user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-0010-2015 Class II Terminated Defective Container: Product leaks when inverted. METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01. 2014-08-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2015 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "69250", "address_1": "7265 Ulmerton Rd", "address_2": "", "code_info": "Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.", "postal_code": "33771-4809", "report_date": "20141015", "product_type": "Drugs", "recall_number": "D-0010-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "322,650 Cups", "termination_date": "20150224", "reason_for_recall": "Defective Container: Product leaks when inverted.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.", "distribution_pattern": "U.S. Nationwide, including Puerto Rico", "recall_initiation_date": "20140813", "initial_firm_notification": "Letter", "center_classification_date": "20141009"} 2026-07-08 15:18:39.181877-07
+mrcl_01kx1wzjpenzm2gmwwndc5grk1 user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-1831-2015 Class III Terminated Defective Container: Lids on unit dose cups are not fully qualified. METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01. 2015-06-26 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1831-2015 {"city": "Largo", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "71601", "address_1": "7265 Ulmerton Rd", "address_2": "N/A", "code_info": "Lot #: 387500, Expiry: 01/17", "postal_code": "33771-4809", "report_date": "20151007", "product_type": "Drugs", "recall_number": "D-1831-2015", "classification": "Class III", "recalling_firm": "VistaPharm, Inc.", "product_quantity": "84,100 Cups", "termination_date": "20170214", "reason_for_recall": "Defective Container: Lids on unit dose cups are not fully qualified.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.", "distribution_pattern": "U.S. Including: CA, IL, LA, OH, PA, and SC.", "recall_initiation_date": "20150626", "initial_firm_notification": "E-Mail", "center_classification_date": "20150928"} 2026-07-08 15:18:39.182214-07
+mrcl_01kx1wzjpe86k204syakteehrq user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-759-2013 Class II Ongoing Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Metoclopramide 5 mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL 2013-05-29 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-759-2013 {"city": "Orlando", "state": "FL", "status": "Ongoing", "country": "United States", "openfda": {}, "event_id": "65360", "address_1": "6700 Conroy Windermere Rd", "address_2": "Suite 140", "code_info": "A5423 Exp 12/31/13", "postal_code": "32835-3500", "report_date": "20130717", "product_type": "Drugs", "recall_number": "D-759-2013", "classification": "Class II", "recalling_firm": "Lowlite Investments, Inc. D/B/A Olympia Pharmacy", "product_quantity": "1", "reason_for_recall": "Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metoclopramide 5 mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL", "distribution_pattern": "Nationwide and PR", "recall_initiation_date": "20130529", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20130711"} 2026-07-08 15:18:39.18252-07
+mrcl_01kx1wzjpeg6gk4tfdtfhcrd4z user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-012-2014 Class II Terminated Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01 2013-09-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-012-2014 {"city": "Lake Forest", "state": "IL", "status": "Terminated", "country": "United States", "openfda": {"unii": ["W1792A2RVD"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["311670"], "spl_id": ["d913cdad-c1da-40b5-b72f-4e6a143971e6"], "brand_name": ["METOCLOPRAMIDE"], "spl_set_id": ["373ba08b-33ad-49fc-28a7-928e89a65314"], "package_ndc": ["0409-3414-18", "0409-3414-01", "0409-3414-21", "0409-3414-11"], "product_ndc": ["0409-3414"], "generic_name": ["METOCLOPRAMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METOCLOPRAMIDE HYDROCHLORIDE"], "manufacturer_name": ["Hospira, Inc."], "application_number": ["ANDA073118"], "is_original_packager": [true]}, "event_id": "66422", "address_1": "275 N Field Dr", "address_2": "", "code_info": "Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)", "postal_code": "60045-2579", "report_date": "20131127", "product_type": "Drugs", "recall_number": "D-012-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Hospira Inc.", "product_quantity": "251,400 vials", "termination_date": "20141006", "reason_for_recall": "Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20130924", "initial_firm_notification": "Letter", "center_classification_date": "20131120"} 2026-07-08 15:18:39.183044-07
+mrcl_01kx1wzjpfj53e84jy22vwpd56 user_steve med_01kx1wz68wb4xw0cmhzehy0xjz openFDA D-0297-2021 Class II Terminated Chemical contamination; Unknown brown residue adhering to the inside of one vial. Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray) 2021-02-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2021 {"city": "Parsippany", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"unii": ["W1792A2RVD"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "rxcui": ["311670"], "spl_id": ["e4deb814-efe2-4ed2-84e6-fc9cde89d9e5"], "brand_name": ["METOCLOPRAMIDE"], "spl_set_id": ["cccf04bd-7463-40b8-a41f-cb1093c358d7"], "package_ndc": ["0703-4502-01", "0703-4502-04"], "product_ndc": ["0703-4502"], "generic_name": ["METOCLOPRAMIDE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["METOCLOPRAMIDE HYDROCHLORIDE"], "manufacturer_name": ["Teva Parenteral Medicines, Inc."], "application_number": ["ANDA073135"], "is_original_packager": [true]}, "event_id": "87330", "address_1": "400 Interpace Pkwy", "address_2": "", "code_info": "Lot # 31325335B, exp. date 07/2021", "postal_code": "07054-1120", "report_date": "20210310", "product_type": "Drugs", "recall_number": "D-0297-2021", "classification": "Class II", "more_code_info": "", "recalling_firm": "Teva Pharmaceuticals USA", "product_quantity": "9,452 cartons", "termination_date": "20210826", "reason_for_recall": "Chemical contamination; Unknown brown residue adhering to the inside of one vial.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)", "distribution_pattern": "Nationwide, including Puerto Rico", "recall_initiation_date": "20210215", "initial_firm_notification": "Letter", "center_classification_date": "20210303"} 2026-07-08 15:18:39.183488-07
+mrcl_01kx1wzk2q7611s81m5s7vds2m user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-559-2014 Class II Terminated Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014. HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-559-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65707", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "HYOSCYAMINE SULFATE ER Tablet, 0.375 mg has the following code Pedigree: W003576, EXP: 6/24/2014.", "postal_code": "98684-3501", "report_date": "20140122", "product_type": "Drugs", "recall_number": "D-559-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "99 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140116"} 2026-07-08 15:18:39.575571-07
+mrcl_01kx1wzk2rv6krgpx0k1bfbgvw user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-826-2013 Class II Terminated Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall. Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. 2013-06-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-826-2013 {"city": "Tulsa", "state": "OK", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65601", "address_1": "12515 E 55th St Ste 100", "address_2": "N/A", "code_info": "Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A", "postal_code": "74146-6234", "report_date": "20130807", "product_type": "Drugs", "recall_number": "D-826-2013", "classification": "Class II", "more_code_info": "", "recalling_firm": "Physicians Total Care, Inc.", "product_quantity": "270 tablets", "termination_date": "20130815", "reason_for_recall": "Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.", "distribution_pattern": "GA", "recall_initiation_date": "20130617", "initial_firm_notification": "FAX", "center_classification_date": "20130726"} 2026-07-08 15:18:39.5765-07
+mrcl_01kx1wzk2snj1d09e37jghmg2d user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-1359-2019 Class II Terminated cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076. 2019-05-21 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1359-2019 {"city": "Levittown", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "82889", "address_1": "2091 Hartel Ave", "address_2": "N/A", "code_info": "Lot #s: 17E039, Exp. 05/2019; 17K016, Exp. 10/2019; 18E021, Exp. 05/2020; 18G008, Exp. 07/2020.", "postal_code": "19057-4506", "report_date": "20190619", "product_type": "Drugs", "recall_number": "D-1359-2019", "classification": "Class II", "recalling_firm": "Torrent Pharma Inc", "product_quantity": "53,520 bottles", "termination_date": "20201006", "reason_for_recall": "cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.", "distribution_pattern": "Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.", "recall_initiation_date": "20190521", "initial_firm_notification": "Letter", "center_classification_date": "20190613"} 2026-07-08 15:18:39.577142-07
+mrcl_01kx1wzk2s166xn8sx7jhrd570 user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-0159-2017 Class II Terminated CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10 2016-10-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2017 {"city": "Richland", "state": "MS", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "75566", "address_1": "199 Interstate Dr Ste N", "address_2": "", "code_info": "LOT # 29421501, EXP 10/17", "postal_code": "39218-9433", "report_date": "20161207", "product_type": "Drugs", "recall_number": "D-0159-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "Burel Pharmaceuticals Inc", "product_quantity": "604 bottles", "termination_date": "20170814", "reason_for_recall": "CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10", "distribution_pattern": "Nationwide", "recall_initiation_date": "20161024", "initial_firm_notification": "E-Mail", "center_classification_date": "20161129"} 2026-07-08 15:18:39.578067-07
+mrcl_01kx1wzk2tbqq7w38d5fvnejqm user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-1044-2016 Class III Terminated Chemical Contamination: Bottles may contain broken dessicants Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10 2016-05-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1044-2016 {"city": "Tampa", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "74251", "address_1": "2649 Causeway Center Dr", "address_2": "N/A", "code_info": "Lot #: 638J011A", "postal_code": "33619-6102", "report_date": "20160629", "product_type": "Drugs", "recall_number": "D-1044-2016", "classification": "Class III", "recalling_firm": "Virtus Pharmaceuticals, Llc", "product_quantity": "24,614 bottles", "termination_date": "20180821", "reason_for_recall": "Chemical Contamination: Bottles may contain broken dessicants", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10", "distribution_pattern": "Nationwide & Puerto Rico.", "recall_initiation_date": "20160513", "initial_firm_notification": "E-Mail", "center_classification_date": "20160620"} 2026-07-08 15:18:39.578584-07
+mrcl_01kx1wzk2t630xwffzze6gkdv9 user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-0866-2023 Class II Terminated CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05 2023-05-25 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2023 {"city": "Canonsburg", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "92366", "address_1": "1000 Mylan Blvd", "address_2": "", "code_info": "Lot #: 101241A, Exp 10/23", "postal_code": "15317-5853", "report_date": "20230614", "product_type": "Drugs", "recall_number": "D-0866-2023", "classification": "Class II", "more_code_info": "", "recalling_firm": "Viatris Inc", "product_quantity": "2,736 boxes", "termination_date": "20240411", "reason_for_recall": "CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05", "distribution_pattern": "Product was distributed to 10 distributors who may have further distribute the product to the retail level.", "recall_initiation_date": "20230525", "initial_firm_notification": "Letter", "center_classification_date": "20230605"} 2026-07-08 15:18:39.578975-07
+mrcl_01kx1wzk2v853g2vd7gh06qwv6 user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-1488-2020 Class II Terminated cGMP deviations VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24. 2020-07-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1488-2020 {"city": "Chester Springs", "state": "PA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "86069", "address_1": "1208 Kimberton Rd Ste 101", "address_2": "", "code_info": "LOT M823J18-1, M823J18-2, M823J18-3 EXP 09/20; LOT M823D19-1 EXP 04/21", "postal_code": "19425-1437", "report_date": "20200812", "product_type": "Drugs", "recall_number": "D-1488-2020", "classification": "Class II", "more_code_info": "", "recalling_firm": "Vilvet Pharmaceuticals Inc.", "product_quantity": "1,716 bottles", "termination_date": "20220121", "reason_for_recall": "cGMP deviations", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24.", "distribution_pattern": "Nationwide within the US", "recall_initiation_date": "20200724", "initial_firm_notification": "Letter", "center_classification_date": "20200806"} 2026-07-08 15:18:39.579813-07
+mrcl_01kx1wzk2wsb4xej7k36wk6zwz user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-170-2013 Class II Terminated Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 2013-01-07 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-170-2013 {"city": "Eatontown", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "64107", "address_1": "465 Industrial Way W", "address_2": "N/A", "code_info": "Lot #: 69099A, 69099B, Exp 08/15", "postal_code": "07724-2209", "report_date": "20130306", "product_type": "Drugs", "recall_number": "D-170-2013", "classification": "Class II", "recalling_firm": "West-ward Pharmaceutical Corp.", "product_quantity": "6,511 bottles", "termination_date": "20150121", "reason_for_recall": "Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724", "distribution_pattern": "Nationwide", "recall_initiation_date": "20130107", "initial_firm_notification": "Letter", "center_classification_date": "20130227"} 2026-07-08 15:18:39.580313-07
+mrcl_01kx1wzk2w94czm7zmbb4bb8xr user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-958-2014 Class II Terminated Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014. HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574024701. 2013-07-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-958-2014 {"city": "Vancouver", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "65690", "address_1": "14301 Se 1st St", "address_2": "", "code_info": "HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg has the following codes: Pedigree: W003614, EXP: 6/25/2014.", "postal_code": "98684-3501", "report_date": "20140129", "product_type": "Drugs", "recall_number": "D-958-2014", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aidapak Services, LLC", "product_quantity": "101 Tablets", "termination_date": "20140207", "reason_for_recall": "Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574024701.", "distribution_pattern": "Repacked drugs were distributed in Arizona, California, Oregon, and Washington.", "recall_initiation_date": "20130702", "initial_firm_notification": "Telephone", "center_classification_date": "20140120"} 2026-07-08 15:18:39.580993-07
+mrcl_01kx1wzk2xd68vgw9cm3me5pdv user_steve med_01kx1wz68x1fctsf3g5rkwdsah openFDA D-0213-2017 Class I Terminated Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10. 2016-09-02 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2017 {"city": "Nashville", "state": "TN", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "75146", "address_1": "1321 Murfreesboro Pike #", "address_2": "N/A", "code_info": "Lot #: 30011601, Exp 01/18", "postal_code": "37217-2726", "report_date": "20161228", "product_type": "Drugs", "recall_number": "D-0213-2017", "classification": "Class I", "recalling_firm": "VIRTUS PHARMACEUTICALS OPCO II L", "product_quantity": "10,572 bottles", "termination_date": "20190923", "reason_for_recall": "Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.", "distribution_pattern": "Nationwide and Puerto Rico", "recall_initiation_date": "20160902", "initial_firm_notification": "E-Mail", "center_classification_date": "20161222"} 2026-07-08 15:18:39.58172-07
+mrcl_01kx1wzkf7yb323yrsqre1ay2p user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0159-2022 Class II Terminated Lack of assurance of sterility TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 2021-10-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2022 {"city": "San Antonio", "state": "TX", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88862", "address_1": "2950 Thousand Oaks Dr Ste 25", "address_2": "N/A", "code_info": "Lot: T1007072021:98 BUD: 01/03/2022; T1005252021:31 BUD: 11/21/2021; T1009222021:60 BUD: 03/21/2022", "postal_code": "78247-3347", "report_date": "20211117", "product_type": "Drugs", "recall_number": "D-0159-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Vita Pharmacy, LLC dba Talon Compounding Pharmacy", "product_quantity": "13 vials", "termination_date": "20231004", "reason_for_recall": "Lack of assurance of sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247", "distribution_pattern": "United States including Washington, D.C. and Puerto Rico", "recall_initiation_date": "20211012", "initial_firm_notification": "Telephone", "center_classification_date": "20211108"} 2026-07-08 15:18:39.976095-07
+mrcl_01kx1wzkf8h4cnk90mndbydrt9 user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0151-2022 Class II Terminated Lack of assurance of sterility TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247 2021-10-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2022 {"city": "San Antonio", "state": "TX", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "88862", "address_1": "2950 Thousand Oaks Dr Ste 25", "address_2": "N/A", "code_info": "Lot: 07292021:54 BUD: 01/25/2022; T1006302021:96 BUD: 12/27/2021; T1008092021:60 BUD: 02/05/2022; T1009222021:51 BUD: 03/21/2022; T1006082021:79 BUD: 12/05/2021; T1008302021:82 BUD: 02/26/2022;", "postal_code": "78247-3347", "report_date": "20211117", "product_type": "Drugs", "recall_number": "D-0151-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Vita Pharmacy, LLC dba Talon Compounding Pharmacy", "product_quantity": "23 vials", "termination_date": "20231004", "reason_for_recall": "Lack of assurance of sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247", "distribution_pattern": "United States including Washington, D.C. and Puerto Rico", "recall_initiation_date": "20211012", "initial_firm_notification": "Telephone", "center_classification_date": "20211108"} 2026-07-08 15:18:39.97671-07
+mrcl_01kx1wzkf991b67cyjwaqk6n4p user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0126-2017 Class II Terminated Superpotent and Subpotent drugs Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network 2016-09-19 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0126-2017 {"city": "Dyersburg", "state": "TN", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "75247", "address_1": "450 US Hwy 51 Byp N", "address_2": "", "code_info": "BUD: 10/04/2016, Lot number 04072016@40 BUD: 12/03/2016, Lot number 06162016@2 BUD: 01/07/2017, Lot number CA07112016@4", "postal_code": "38024-3655", "report_date": "20161116", "product_type": "Drugs", "recall_number": "D-0126-2017", "classification": "Class II", "more_code_info": "", "recalling_firm": "Wells Pharmacy Network, LLC", "product_quantity": "690 pellets", "termination_date": "20170329", "reason_for_recall": "Superpotent and Subpotent drugs", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network", "distribution_pattern": "U.S.", "recall_initiation_date": "20160919", "initial_firm_notification": "Telephone", "center_classification_date": "20161108"} 2026-07-08 15:18:39.977088-07
+mrcl_01kx1wzkf9095rcmtmnhy41bvv user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0652-2018 Class II Terminated Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride 80mg/8mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, twist top surrounded by a wrapper 2018-03-22 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2018 {"city": "Las Vegas", "state": "NV", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79619", "address_1": "5835 S Eastern Ave Ste 101", "address_2": "", "code_info": "Lot#: 20171010@76, BUD: 04/08/2018.", "postal_code": "89119-3031", "report_date": "20180425", "product_type": "Drugs", "recall_number": "D-0652-2018", "classification": "Class II", "more_code_info": "", "recalling_firm": "Partell Specialty Pharmacy", "product_quantity": "1 vial", "termination_date": "20190115", "reason_for_recall": "Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride 80mg/8mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, twist top surrounded by a wrapper", "distribution_pattern": "NV only", "recall_initiation_date": "20180322", "initial_firm_notification": "Letter", "center_classification_date": "20180417"} 2026-07-08 15:18:39.977609-07
+mrcl_01kx1wzkfayjn63xmd7qd1gtkb user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0146-2016 Class II Terminated Lack of Assurance of Sterility; all sterile human compounded drugs within expiry TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 2015-07-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2016 {"city": "Moses Lake", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "71806", "address_1": "1555 Pilgrim St", "address_2": "N/A", "code_info": "t09262014@23, t07282014@9, t07012014@11, t06092015@8, t05132015@6, t02172015@13, t01232015@7, 07222015@1.", "postal_code": "98837-4623", "report_date": "20151104", "product_type": "Drugs", "recall_number": "D-0146-2016", "classification": "Class II", "recalling_firm": "JD & SN Inc., dba Moses Lake Professional Pharmacy", "product_quantity": "60 pellets", "termination_date": "20160413", "reason_for_recall": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150724", "initial_firm_notification": "Press Release", "center_classification_date": "20151027"} 2026-07-08 15:18:39.97814-07
+mrcl_01kx1wzkfavsk3tc234a5k906c user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0654-2018 Class II Terminated Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 2018-03-22 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0654-2018 {"city": "Las Vegas", "state": "NV", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79619", "address_1": "5835 S Eastern Ave Ste 101", "address_2": "", "code_info": "Lot#: 20180111@104, BUD 07/10/2018.", "postal_code": "89119-3031", "report_date": "20180425", "product_type": "Drugs", "recall_number": "D-0654-2018", "classification": "Class II", "more_code_info": "", "recalling_firm": "Partell Specialty Pharmacy", "product_quantity": "one vial", "termination_date": "20190115", "reason_for_recall": "Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800", "distribution_pattern": "NV only", "recall_initiation_date": "20180322", "initial_firm_notification": "Letter", "center_classification_date": "20180417"} 2026-07-08 15:18:39.978816-07
+mrcl_01kx1wzkfbza7dra8dmegr1wej user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0161-2018 Class II Terminated Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. 2017-11-16 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0161-2018 {"city": "Boca Raton", "state": "FL", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "78553", "address_1": "791 Park of Commerce Blvd Ste 600", "address_2": "N/A", "code_info": "Lots: 03092017@21 BUD: 3/9/2018; 03292017@33 BUD: 3/24/2018; 05092017@38 BUD: 5/4/2018; 05162017@31 BUD: 5/11/2018; 05182017@25 BUD: 5/13/2018; 07032017@40 BUD: 6/28/2018; 07142017@34 BUD: 7/9/2018; 07192017@32 BUD: 7/14/2018; 08282017@25 BUD: 8/23/2018; 09142017@8BUD: 9/9/2018; 09212017@23 BUD: 9/16/2018; 09272017@36 BUD: 9/ 22/2018; 10162017@39 BUD: 10/11/2018; 11032017@28 BUD: 10/29/2018", "postal_code": "33487-3633", "report_date": "20180117", "product_type": "Drugs", "recall_number": "D-0161-2018", "classification": "Class II", "more_code_info": "", "recalling_firm": "KRS Global Biotechnology, Inc", "product_quantity": "15,700 capsules", "termination_date": "20200511", "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.", "distribution_pattern": "Nationwide in the USA, Bermuda, and New Zealand", "recall_initiation_date": "20171116", "initial_firm_notification": "Letter", "center_classification_date": "20180108"} 2026-07-08 15:18:39.979367-07
+mrcl_01kx1wzkfbj9bw7gfnnw6bzz0d user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0672-2018 Class II Terminated Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. 2018-03-22 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0672-2018 {"city": "Las Vegas", "state": "NV", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "79619", "address_1": "5835 S Eastern Ave Ste 101", "address_2": "", "code_info": "Lot#: 20171122@65, BUD 05/21/2018; 20171115@56, BUD 05/14/2018; 20171002@77, BUD 03/31/2018; 20171006@63, BUD 04/04/2018; 20171009@55, BUD 04/07/2018; 20171117@72, BUD 05/16/2018.", "postal_code": "89119-3031", "report_date": "20180425", "product_type": "Drugs", "recall_number": "D-0672-2018", "classification": "Class II", "more_code_info": "", "recalling_firm": "Partell Specialty Pharmacy", "product_quantity": "", "termination_date": "20190115", "reason_for_recall": "Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.", "distribution_pattern": "NV only", "recall_initiation_date": "20180322", "initial_firm_notification": "Letter", "center_classification_date": "20180417"} 2026-07-08 15:18:39.980042-07
+mrcl_01kx1wzkfcwb8hxd14e3qf998p user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-0145-2016 Class II Terminated Lack of Assurance of Sterility; all sterile human compounded drugs within expiry TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 2015-07-24 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0145-2016 {"city": "Moses Lake", "state": "WA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "71806", "address_1": "1555 Pilgrim St", "address_2": "N/A", "code_info": "t05132014@15, t08262014@18, t11112014@21.", "postal_code": "98837-4623", "report_date": "20151104", "product_type": "Drugs", "recall_number": "D-0145-2016", "classification": "Class II", "recalling_firm": "JD & SN Inc., dba Moses Lake Professional Pharmacy", "product_quantity": "20 pellets", "termination_date": "20160413", "reason_for_recall": "Lack of Assurance of Sterility; all sterile human compounded drugs within expiry", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150724", "initial_firm_notification": "Press Release", "center_classification_date": "20151027"} 2026-07-08 15:18:39.98068-07
+mrcl_01kx1wzkfd2a7sp9mwsfpydewd user_steve med_01kx1wz68x3nf9cpyrkzm7142r openFDA D-1467-2019 Class II Terminated GMP Deviations: Potential cross contamination due to cleaning procedure failure. Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories 2019-05-09 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1467-2019 {"city": "Columbus", "state": "OH", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000175563", "N0000175080"], "upc": ["0368001155045"], "unii": ["2Z07MYW1AZ"], "route": ["ORAL"], "rxcui": ["199224"], "spl_id": ["2dc9d4ae-4fbc-df45-e063-6394a90a09a0"], "brand_name": ["ANASTROZOLE"], "spl_set_id": ["3cd04ed6-7c5a-4c4a-9955-ee40839dfea0"], "package_ndc": ["68001-155-04", "68001-155-08"], "product_ndc": ["68001-155"], "generic_name": ["ANASTROZOLE"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "substance_name": ["ANASTROZOLE"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "application_number": ["ANDA078921"], "is_original_packager": [true]}, "event_id": "83290", "address_1": "2550 John Glenn Ave Ste A", "address_2": "", "code_info": "Count, Lot, Expiry: [30-count bottle] Lots M711214, M711215, M711216, M711217, exp 8/31/2019; Lots M802198, M802199, exp 1/31/2020; Lots M805203, M805204, M805207, exp 3/31/2019; Lots M812455, exp 6/30/2020; Lot M815766, exp 9/30/2020; Lots M818633, M818634, exp 10/31/2020; Lots M819858, M819859, exp 11/30/2020 [1000-count bottle] Lot M711218, exp 8/31/2019; Lot M802197, exp 1/31/2020; Lots M805209, M805946, exp 3/31/2020; Lot M812456, exp 6/30/2020; Lots M815767, M818273, exp 9/30/2020; Lot M819857, exp 11/30/2020", "postal_code": "43217-1188", "report_date": "20190717", "product_type": "Drugs", "recall_number": "D-1467-2019", "classification": "Class II", "more_code_info": "", "recalling_firm": "American Health Packaging", "product_quantity": "375,921 bottles", "termination_date": "20200909", "reason_for_recall": "GMP Deviations: Potential cross contamination due to cleaning procedure failure.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories", "distribution_pattern": "Nationwide USA", "recall_initiation_date": "20190509", "initial_firm_notification": "Letter", "center_classification_date": "20190710"} 2026-07-08 15:18:39.9812-07
+mrcl_01kx1wzktxdte86avprzz9vjnm user_steve med_01kx1wz68xsgmnrqtgd72v5777 openFDA D-594-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Clomiphene Citrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-594-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-594-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "1550 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Clomiphene Citrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:40.349639-07
+mrcl_01kx1wzktyzxvdk3r5rjsztrjd user_steve med_01kx1wz68xsgmnrqtgd72v5777 openFDA D-1813-2015 Class III Terminated Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7. 2015-09-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1813-2015 {"city": "Rockland", "state": "MA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "72172", "address_1": "1 Technology Pl", "address_2": "", "code_info": "Lot #: 233169, Exp 02/16", "postal_code": "02370-1071", "report_date": "20150923", "product_type": "Drugs", "recall_number": "D-1813-2015", "classification": "Class III", "more_code_info": "", "recalling_firm": "EMD Serono, Inc.", "product_quantity": "37,078 cartons", "termination_date": "20170213", "reason_for_recall": "Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20150910", "initial_firm_notification": "Letter", "center_classification_date": "20150915"} 2026-07-08 15:18:40.350412-07
+mrcl_01kx1wzktyjzvjnjsb6brvapd6 user_steve med_01kx1wz68xsgmnrqtgd72v5777 openFDA D-1041-2022 Class II Terminated cGMP deviations: Temperature abuse ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55 2022-04-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1041-2022 {"city": "Richmond", "state": "VA", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "89646", "address_1": "9954 Maryland Drive", "address_2": "Deep Run Iii Ste. 4000", "code_info": "McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.", "postal_code": "23233", "report_date": "20220615", "product_type": "Drugs", "recall_number": "D-1041-2022", "classification": "Class II", "more_code_info": "", "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office", "product_quantity": "240 cartons/3 blister packs per carton", "termination_date": "20231130", "reason_for_recall": "cGMP deviations: Temperature abuse", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55", "distribution_pattern": "USA nationwide.", "recall_initiation_date": "20220413", "initial_firm_notification": "Letter", "center_classification_date": "20220609"} 2026-07-08 15:18:40.351-07
+mrcl_01kx1wzm8b04ajv9w1eqjex6fk user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-0337-2015 Class II Terminated Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11 2014-12-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2015 {"city": "Elizabeth", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"upc": ["0731477272217"], "rxcui": ["310431"], "spl_id": ["b43e4780-f902-89d9-e053-2a95a90a6792"], "brand_name": ["GABA 300-EZS"], "spl_set_id": ["bb29692e-1546-4d05-a46a-93baf4172c7d"], "package_ndc": ["59088-725-00", "45963-556-11"], "product_ndc": ["59088-725"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "manufacturer_name": ["PureTek Corporation"], "is_original_packager": [true]}, "event_id": "70001", "address_1": "200 Elmora Ave", "address_2": "N/A", "code_info": "Lot #s: G01960A1, Exp 09/2015, G01967A1, Exp 10/2015", "postal_code": "07202-1106", "report_date": "20150114", "product_type": "Drugs", "recall_number": "D-0337-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Actavis Elizabeth LLC", "product_quantity": "24,240 Bottles", "termination_date": "20151120", "reason_for_recall": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11", "distribution_pattern": "Puerto Rico", "recall_initiation_date": "20141215", "initial_firm_notification": "Letter", "center_classification_date": "20150108"} 2026-07-08 15:18:40.779764-07
+mrcl_01kx1wzm8c2jts5frwyqymt5sg user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-0354-2023 Class III Terminated Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05. 2023-02-17 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0354-2023 {"city": "Hauppauge", "state": "NY", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0350228180108", "0350228180054", "0350228181013", "0350228178013", "0350228181051", "0350228179010", "0350228180016", "0350228177016", "0350228179102", "0350228178051", "0350228177054"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["176515ec-fdba-417a-b849-86aea6fd7857"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["5ab9c18b-9568-4dcb-90b0-252aef8f8dc2"], "package_ndc": ["50228-177-30", "50228-177-01", "50228-177-05", "50228-178-30", "50228-178-01", "50228-178-05"], "product_ndc": ["50228-177", "50228-178"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "application_number": ["ANDA205101"], "is_original_packager": [true]}, "event_id": "91717", "address_1": "89 Arkay Dr", "address_2": "N/A", "code_info": "Lot # G177092, Exp. 11/24", "postal_code": "11788-3727", "report_date": "20230308", "product_type": "Drugs", "recall_number": "D-0354-2023", "classification": "Class III", "more_code_info": "", "recalling_firm": "Sciegen Pharmaceuticals Inc", "product_quantity": "4,392 bottles", "termination_date": "20240617", "reason_for_recall": "Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.", "distribution_pattern": "Nationwide in the USA and Puerto Rico", "recall_initiation_date": "20230217", "initial_firm_notification": "Letter", "center_classification_date": "20230227"} 2026-07-08 15:18:40.780749-07
+mrcl_01kx1wzm8dg3qwsnbdy8qfwg9c user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-0208-2020 Class II Terminated Lack of Assurance of Sterility S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx 2019-08-12 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0208-2020 {"city": "Mesa", "state": "AZ", "status": "Terminated", "country": "United States", "openfda": {}, "event_id": "83669", "address_1": "6828 E Brown Rd Ste 101", "address_2": "N/A", "code_info": "Lot #: S07312019DH@15, Exp 8/31/19", "postal_code": "85207-3761", "report_date": "20191113", "product_type": "Drugs", "recall_number": "D-0208-2020", "classification": "Class II", "recalling_firm": "First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy", "product_quantity": "N/A", "termination_date": "20230413", "reason_for_recall": "Lack of Assurance of Sterility", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20190812", "initial_firm_notification": "Letter", "center_classification_date": "20191105"} 2026-07-08 15:18:40.781487-07
+mrcl_01kx1wzm8dbptjb5bwepymqjzv user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-1232-2020 Class II Terminated CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99 2020-03-18 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1232-2020 {"city": "East Windsor", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["7a45ad84-02a4-442d-8401-1a1495d084fa"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["1a619a14-0b63-4cba-80e7-474c9a1c90b9"], "package_ndc": ["65862-198-01", "65862-198-05", "65862-198-99", "65862-198-10", "65862-198-90", "65862-198-18", "65862-198-27", "65862-199-01", "65862-199-05", "65862-199-99", "65862-199-10", "65862-199-30", "65862-199-60", "65862-199-90", "65862-199-18", "65862-199-27", "65862-200-01", "65862-200-05", "65862-200-10", "65862-200-90", "65862-200-27"], "product_ndc": ["65862-198", "65862-199", "65862-200"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Aurobindo Pharma Limited"], "application_number": ["ANDA078787"], "is_original_packager": [true]}, "event_id": "85183", "address_1": "279 Princeton Hightstown Rd", "address_2": "", "code_info": "Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021", "postal_code": "08520-1401", "report_date": "20200422", "product_type": "Drugs", "recall_number": "D-1232-2020", "classification": "Class II", "more_code_info": "", "recalling_firm": "Aurobindo Pharma USA Inc.", "product_quantity": "26625 units", "termination_date": "20240325", "reason_for_recall": "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99", "distribution_pattern": "Nationwide within the United States", "recall_initiation_date": "20200318", "initial_firm_notification": "Letter", "center_classification_date": "20200413"} 2026-07-08 15:18:40.782102-07
+mrcl_01kx1wzm8e2wkb7vx57cjc4hj8 user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-696-2015 Class II Terminated Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Gabapentin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 2014-11-14 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-696-2015 {"city": "Toronto", "state": "", "status": "Terminated", "country": "Canada", "openfda": {}, "event_id": "70452", "address_1": "184 Front St E", "address_2": "unit 801", "code_info": "All lots repackaged and distributed between 01/05/12 to 02/12/15", "postal_code": "N/A", "report_date": "20150429", "product_type": "Drugs", "recall_number": "D-696-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Attix Pharmaceuticals", "product_quantity": "365402 grams", "termination_date": "20151007", "reason_for_recall": "Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada", "distribution_pattern": "Nationwide to compounding pharmacies and research organizations.", "recall_initiation_date": "20141114", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "center_classification_date": "20150420"} 2026-07-08 15:18:40.783048-07
+mrcl_01kx1wzm8fknk2d6e6yk7trf0t user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-0031-2026 Class II Ongoing Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). 2025-10-10 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0031-2026 {"city": "Dublin", "state": "OH", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0055154336307", "0055154799201"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["b6880b32-3ebc-4b0e-8a84-d513f3e401af", "b64683a2-7521-4a16-8fc7-4974606e2e3b"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["36f74fdf-0dae-47a0-a7ea-e64ac91cd88f", "41844c21-9e2a-4332-a8ff-9b71ae9032b0"], "package_ndc": ["0904-6665-61", "0904-6666-61", "0904-6667-61", "55154-3363-0", "55154-7992-0", "55154-7993-0"], "product_ndc": ["0904-6665", "0904-6666", "0904-6667", "55154-3363", "55154-7992", "55154-7993"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Major Pharmaceuticals", "Cardinal Health 107, LLC"], "application_number": ["ANDA090858"], "original_packager_product_ndc": ["67877-222", "67877-223", "67877-224", "0904-6665", "0904-6666", "0904-6667"]}, "event_id": "97777", "address_1": "7000 Cardinal Pl", "address_2": "", "code_info": "Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.", "postal_code": "43017-1091", "report_date": "20251029", "product_type": "Drugs", "recall_number": "D-0031-2026", "classification": "Class II", "more_code_info": "", "recalling_firm": "The Harvard Drug Group LLC", "product_quantity": "", "reason_for_recall": "Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).", "distribution_pattern": "US Nationwide.", "recall_initiation_date": "20251010", "initial_firm_notification": "", "center_classification_date": "20251017"} 2026-07-08 15:18:40.783844-07
+mrcl_01kx1wzm8gng580e3hpg0g4ewm user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-0320-2025 Class II Ongoing CGMP Deviations Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05. 2025-03-13 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2025 {"city": "Mahwah", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0368462127018", "0368462126011"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["4da1bae0-701b-4b65-a01e-f4bcedfad849"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["3865a6e3-112c-490c-82ac-35401336b16e"], "package_ndc": ["68462-126-01", "68462-126-05", "68462-127-01", "68462-127-05"], "product_ndc": ["68462-126", "68462-127"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA077662"], "is_original_packager": [true]}, "event_id": "96474", "address_1": "750 Corporate Dr", "address_2": "N/A", "code_info": "Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25", "postal_code": "07430-2009", "report_date": "20250416", "product_type": "Drugs", "recall_number": "D-0320-2025", "classification": "Class II", "recalling_firm": "Glenmark Pharmaceuticals Inc., USA", "product_quantity": "N/A", "reason_for_recall": "CGMP Deviations", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.", "distribution_pattern": "U.S. Nationwide", "recall_initiation_date": "20250313", "initial_firm_notification": "Letter", "center_classification_date": "20250408"} 2026-07-08 15:18:40.78461-07
+mrcl_01kx1wzm8h82xyrp2vxn9sxbh3 user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-0312-2025 Class III Ongoing Cross Contamination Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. 2025-03-04 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0312-2025 {"city": "Princeton", "state": "NJ", "status": "Ongoing", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0362756204010", "0362756202016", "0362756138025", "0362756137028", "0362756139022"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "spl_id": ["aff50a15-df39-495f-a145-0ba59660eed8"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["c9a05f0c-b5f0-422c-9d67-6d0efc921a74"], "package_ndc": ["62756-137-02", "62756-137-03", "62756-137-05", "62756-137-04", "62756-137-01", "62756-138-02", "62756-138-03", "62756-138-05", "62756-138-04", "62756-138-01", "62756-139-02", "62756-139-03", "62756-139-05", "62756-139-04", "62756-139-01", "62756-202-01", "62756-202-03", "62756-204-01", "62756-204-03"], "product_ndc": ["62756-137", "62756-138", "62756-139", "62756-202", "62756-204"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "application_number": ["ANDA077242"], "is_original_packager": [true]}, "event_id": "96415", "address_1": "2 Independence Way", "address_2": "N/A", "code_info": "Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025", "postal_code": "08540-6620", "report_date": "20250416", "product_type": "Drugs", "recall_number": "D-0312-2025", "classification": "Class III", "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "product_quantity": "852 bottles", "reason_for_recall": "Cross Contamination", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.", "distribution_pattern": "Nationwide in the USA", "recall_initiation_date": "20250304", "initial_firm_notification": "Letter", "center_classification_date": "20250404"} 2026-07-08 15:18:40.785257-07
+mrcl_01kx1wzm8h9b2a3335ewg8njn1 user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-329-2013 Class III Terminated Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. 2013-04-05 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-329-2013 {"city": "Mahwah", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0368462127018", "0368462126011"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310433", "310434"], "spl_id": ["4da1bae0-701b-4b65-a01e-f4bcedfad849"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["3865a6e3-112c-490c-82ac-35401336b16e"], "package_ndc": ["68462-126-01", "68462-126-05", "68462-127-01", "68462-127-05"], "product_ndc": ["68462-126", "68462-127"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "application_number": ["ANDA077662"], "is_original_packager": [true]}, "event_id": "64995", "address_1": "750 Corporate Dr", "address_2": "", "code_info": "a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp 10/14 Lot# 02123430, Exp 10/14 Lot# 02123492, Exp 10/14 Lot# 02123523, Exp 10/14 Lot# 02123527, Exp 10/14 Lot# 02123532, Exp 10/14 Lot# 02123542, Exp 10/14 Lot# 02123546, Exp 10/14 Lot# 02123551, Exp 10/14 Lot# 02123555, Exp 10/14 Lot# 02123560, Exp 11/14 Lot# 02123566, Exp 11/14 Lot# 02123569, Exp 11/14 b) 800 mg Lot# 02123440 Exp 10/14 Lot# 02123445 Exp 10/14 Lot# 02123454 Exp 10/14 Lot# 02123465 Exp 10/14 Lot# 02123789 Exp 11/14 Lot# 02123804 Exp 11/14 Lot# 02123821 Exp 11/14 Lot# 02123829 Exp 11/14 Lot# 02123834 Exp 11/14 Lot# 02123841 Exp 11/14 Lot# 02123845 Exp 11/14", "postal_code": "07430-2009", "report_date": "20130522", "product_type": "Drugs", "recall_number": "D-329-2013", "classification": "Class III", "more_code_info": "", "recalling_firm": "Glenmark Generics Inc., USA", "product_quantity": "a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct)", "termination_date": "20141009", "reason_for_recall": "Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430.", "distribution_pattern": "Nationwide", "recall_initiation_date": "20130405", "initial_firm_notification": "Letter", "center_classification_date": "20130516"} 2026-07-08 15:18:40.78604-07
+mrcl_01kx1wzm8j5rfgk6k8m5z7mtph user_steve med_01kx1wz68yreetd9fexbtnh1w4 openFDA D-0336-2015 Class II Terminated Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA. 2014-12-15 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2015 {"city": "Elizabeth", "state": "NJ", "status": "Terminated", "country": "United States", "openfda": {"nui": ["N0000008486"], "upc": ["0345963555113", "0345963556110"], "unii": ["6CW7F3G59X"], "route": ["ORAL"], "rxcui": ["310430", "310431", "310432"], "spl_id": ["63f9a25b-d34f-4b4b-8ccd-e0f6dac569f5"], "brand_name": ["GABAPENTIN"], "spl_set_id": ["5969871e-6c71-4c37-9d63-370718ccc80c"], "package_ndc": ["45963-555-11", "45963-555-50", "45963-556-11", "45963-556-50", "45963-557-11", "45963-557-50", "14550-513-02"], "product_ndc": ["45963-555", "45963-556", "45963-557"], "generic_name": ["GABAPENTIN"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "substance_name": ["GABAPENTIN"], "manufacturer_name": ["Actavis Pharma, Inc."], "application_number": ["ANDA075350"], "is_original_packager": [true]}, "event_id": "70001", "address_1": "200 Elmora Ave", "address_2": "N/A", "code_info": "Lot #s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015", "postal_code": "07202-1106", "report_date": "20150114", "product_type": "Drugs", "recall_number": "D-0336-2015", "classification": "Class II", "more_code_info": "", "recalling_firm": "Actavis Elizabeth LLC", "product_quantity": "10,857 Bottles", "termination_date": "20151120", "reason_for_recall": "Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.", "voluntary_mandated": "Voluntary: Firm initiated", "product_description": "Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.", "distribution_pattern": "Puerto Rico", "recall_initiation_date": "20141215", "initial_firm_notification": "Letter", "center_classification_date": "20150108"} 2026-07-08 15:18:40.786461-07
+\.
+
+
+--
+-- PostgreSQL database dump complete
+--
+
+\unrestrict w1pJsC1vbAhfLqVFmVD3UEPegeqyZUVzBgSLWVgP2aWouS0AJfSEC5EqsgtpnsF
+
← ef35bef claims: add California Unclaimed Property (claimit.ca.gov) r
·
back to AbramsOS
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savings: life-optimizer module — cheaper/better substitutes db2fd48 →