Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amne

Recalled July 1, 2020 · FDA recall D-1347-2020 · 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, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10

Manufacturer(s)

Amneal Pharmaceuticals of New York, LLC

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