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 April 10, 2019 · FDA recall D-1075-2019 · Legacy Pharmaceutical Packaging
Hazard
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. · FDA Class II
Units
179,544 30-count bottles
Sold at
AZ, IN, TN
Description
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
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 →