Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202
Recalled May 8, 2019 · FDA recall D-1263-2019 · Legacy Pharmaceutical Packaging
Hazard
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API) · FDA Class II
Units
60,012 bottles
Sold at
TN, AZ
Description
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
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
Manufacturer(s)
Legacy Pharmaceutical Packaging LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →