Drug 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
D-0249-2021
Product summary
- Event
- Event 87210
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7071 bottles
- Official record key
drug-enforcement:D-0249-2021
Official wording
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Code information: Lot MET200601, 07/2022
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
NDMA) impurity
-
Manufacturing or process control
CGMP Deviations