Metformin Hydrochloride Extended-Release Tablets USP recalled over manufacturing violations

Recall date

August 19, 2020

Source

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

Official notice title

BAYSHORE PHARMACEUTICALS recalls Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceutic…

Recall number

D-1543-2020

FDA classification

Class II

Brand / firm

BAYSHORE PHARMACEUTICALS

Sold / distributed

nationwide

Why it was recalled

CGMP Deviations

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 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10