Nostrum Laboratories Inc recalls Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum
Recalled February 10, 2021 · FDA recall D-0249-2021 · Nostrum Laboratories
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. · FDA Class II
Units
7071 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 →