Time-Cap Labs recalled over manufacturing violations

Recall date

June 5, 2020

Source

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

Official notice title

Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactu…

Recall number

D-1356-2020

FDA classification

Class II

Brand / firm

Marksans Pharma Limited

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

Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01