Drug product

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 Packaging LLC, Earth City, MO 63045 NDC 68645-577-54

D-1048-2019

March 01, 2019

Class II

Product summary

Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Code information: Lots: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-20

Distribution pattern: Wal-Mart distribution centers in AR, CA, GA, IN and MD

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

impurity, N-Methylnitrosobutyric acid (NMBA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations