Earth City, MO, United States
Legacy Pharmaceutical Packaging LLC recalls
5 recalls recorded since 2018, most recently on 11 December 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 11 December 2023
- Reason
- CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
- Distribution
- CA and AR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0205-2024
- Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City,
Terminated Class III Drugs
- Recall started
- 24 September 2020
- Terminated
- 8 November 2022
- Reason
- Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
- Distribution
- Walmart distribution centers in GA and AR
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1626-2020
- Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045
Ongoing Class II Drugs
- Recall started
- 24 April 2019
- Reason
- CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
- Distribution
- TN, AZ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1263-2019
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packag
Ongoing Class II Drugs
- Recall started
- 1 March 2019
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
- Distribution
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1050-2019, D-1048-2019, D-1049-2019
- Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceut
- Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutica
Terminated Class II Drugs
- Recall started
- 1 March 2019
- Terminated
- 29 September 2023
- Reason
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
- Distribution
- AZ, IN, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1075-2019
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.