Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

Recall date

May 27, 2020

Source

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

Official notice title

Apotex Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc.…

Recall number

D-1303-2020

FDA classification

Class II

Brand / firm

Apotex Inc.

Sold / distributed

Nationwide.

Why it was recalled

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

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

What was recalled

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1