Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceu
Recalled July 1, 2020 · FDA recall D-1334-2020 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II
Units
6,540 bottles
Sold at
Product was distributed throughout the United States.
Description
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →