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FDANovember 1, 2020drug

Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

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

The hazard

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

What to do

FDA enforcement status: Terminated

Brands named

preferred pharmaceuticalspreferred

Recall history

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

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