Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

Recall date

June 4, 2020

Source

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

Official notice title

AVKARE Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-61…

Recall number

D-1305-2020

FDA classification

Class II

Brand / firm

AVKARE Inc.

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

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478