Drug recall D-0392-2022
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Reason for recall
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Lots and codes
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
Recall details
- Recalling firm
- VIONA PHARMACEUTICALS INC, Cranford, NJ
- Quantity
- 23,8416/100 count bottles
- Distribution
- Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 27, 2021
- Terminated
- September 20, 2023
Related products
- Metformin hydrochloride – drug information
- NDC 72578-036 Metformin Hydrochloride · Metformin Hydrochloride 750 mg/1 · Viona Pharmaceuticals Inc
- NDC 72578-035 Metformin Hydrochloride · Metformin Hydrochloride 500 mg/1 · Viona Pharmaceuticals Inc