Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum
Recalled January 20, 2021 · FDA recall D-0227-2021 · Nostrum Laboratories
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level · FDA Class II
Units
6958 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 tablets per bottle, 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 →