Class II
Terminated
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
- Company
- Viona Pharmaceuticals Inc
- Recall Initiated
- December 27, 2021
- Posted
- February 2, 2022
- Recall Number
- D-0392-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,8416/100 count bottles
- Firm Location
- Cranford, NJ, United States
Reason for Recall
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Lot / Code Info
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
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