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 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611…

Recall number

D-1304-2020

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 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478