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FDAJune 5, 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); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127

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

pd rx pharmaceuticals

UPCs

49483062301

Recall history

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

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