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FDAOctober 6, 2020drug

metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

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

The hazard

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

What to do

FDA enforcement status: Terminated

Brands named

pd rx pharmaceuticals

Recall history

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

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