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FDAJune 17, 2020drug

Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01

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

UPCs

68788693201

Recall history

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

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