Losartan Potassium Tablets USP 100 mg recalled over manufacturing violations

Recall date

March 26, 2020

Source

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

Official notice title

Avet Pharmaceuticals, Inc. recalls Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 10…

Recall number

D-1104-2020

FDA classification

Class II

Brand / firm

Avet Pharmaceuticals, Inc.

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level

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 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816