Losartan Potassium Tablets USP recalled over manufacturing violations

Recall date

February 28, 2019

Source

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

Official notice title

Camber Pharmaceuticals Inc recalls Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c)…

Recall number

D-1041-2019

FDA classification

Class II

Brand / firm

Camber Pharmaceuticals Inc

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

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, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India