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FDAApril 28, 2021drug

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

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

The hazard

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

What to do

FDA enforcement status: Ongoing

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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