Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmace
Recalled July 22, 2020 · FDA recall D-1384-2020 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II
Units
59,568 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 bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 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 →