Amneal Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

Recall date

May 29, 2020

Source

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

Official notice title

Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pha…

Recall number

D-1353-2020

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable 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

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11