Drug product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
D-0068-2021
Product summary
- Event
- Event 86653
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20,872 bottles
- Official record key
drug-enforcement:D-0068-2021
Official wording
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Code information: MET100201, MET100401 EXP 05/2022
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
NDMA) impurity
-
Manufacturing or process control
CGMP Deviations