Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmac

Recalled July 22, 2020 · FDA recall D-1382-2020 · Lupin Pharmaceuticals

Hazard

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

Units

64,344 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, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01

Manufacturer(s)

Lupin Pharmaceuticals Inc.

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