Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amnea

Recalled July 1, 2020 · FDA recall D-1351-2020 · Amneal Pharmaceuticals of New York

Hazard

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II

Units

N/A

Sold at

Nationwide

Description

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Product

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

Manufacturer(s)

Amneal Pharmaceuticals of New York, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →