Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Labor
Recalled November 11, 2020 · FDA recall D-0067-2021 · Nostrum Laboratories
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II
Units
12,967 bottles
Sold at
Nationwide
Description
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Manufacturer(s)
Nostrum Laboratories Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →