Drug product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
D-0392-2022
Product summary
- Event
- Event 89305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,8416/100 count bottles
- Official record key
drug-enforcement:D-0392-2022
Official wording
Reason: CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Code information: M008130 06/2022, M008131 06/2022, M008132 06/2022, M008133 06/2022, M010080 07/2022, M010081 07/2022, M011029 08/2022, M011030 08/2022, M011031 08/2022, M011032 08/2022, M011304 08/2022, M013394 09/2022, M013395 09/2022, M013396 09/2022, M013966 09/2022, M013967 09/2022, M100831 12/2022, M100832 12/2022, M100833 01/2023, M100834 01/2023, M101267 01/2023, M102718 01/2023, M102719 01/2023
Distribution pattern: Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations