Recalls / Class II

Class IID-1263-2019

Product

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

Affected lot / code info

Lot 181598; 02/2021

Why it was recalled

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

Recalling firm

Firm

Legacy Pharmaceutical Packaging LLC

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

13333 Lakefront Dr, N/A, Earth City, Missouri 63045-1514

Distribution

Quantity

60,012 bottles

Distribution pattern

TN, AZ

Timeline

Recall initiated

2019-04-24

FDA classified

2019-05-01

Posted by FDA

2019-05-08

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1263-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.