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FDAMay 29, 2020drug

amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

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: Ongoing

Brands named

amneal pharmaceuticalsamneal

UPCs

53746017805

Recall history

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

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amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05 — Recall Details · AllClear