Losartan Potassium Tablets recalled over manufacturing violations

Recall date

March 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Ma…

Recall number

D-1048-2019

FDA classification

Class II

Brand / firm

Legacy Pharmaceutical Packaging LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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