Heritage Pharmaceuticals product recalled over manufacturing violations

Recall date

May 3, 2019

Source

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

Official notice title

Heritage Pharmaceuticals, Inc. recalls Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Pl…

Recall number

D-1288-2019

FDA classification

Class II

Brand / firm

Heritage 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 at the manufacturer

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 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09