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FDAJune 5, 2020drug

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

marksans pharmamarksans

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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