Amneal Pharmaceuticals of New York, LLC recalls amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amn
Recalled July 1, 2020 · FDA recall D-1349-2020 · 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, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10
Manufacturer(s)
Amneal Pharmaceuticals of New York, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →