Home / Recalls / Legacy Pharmaceutical Packaging LLC / D-1263-2019

D-1263-2019 Class II Ongoing

Recalled by Legacy Pharmaceutical Packaging LLC — Earth City, MO

Recall Details

Product Type
Drugs
Report Date
May 8, 2019
Initiation Date
April 24, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60,012 bottles

Product Description

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 by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

Reason for Recall

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Distribution Pattern

TN, AZ

Code Information

Lot 181598; 02/2021

Other recalls by Legacy Pharmaceutical Packaging LLC

  • D-0205-2024 Class II — Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, (December 11, 2023)
  • D-1626-2020 Class III — Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufa (September 24, 2020)
  • D-1049-2019 Class II — Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed (March 1, 2019)
  • D-1048-2019 Class II — Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed (March 1, 2019)
  • D-1075-2019 Class II — Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed (March 1, 2019)
  • D-1050-2019 Class II — Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distribute (March 1, 2019)
  • D-0606-2017 Class II — ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Krog (March 7, 2017)
  • D-1363-2014 Class II — Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) un (April 9, 2014)
  • D-1279-2014 Class II — Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal- (February 14, 2014)
  • D-319-2013 Class II — Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufacture (April 22, 2013)