D-0392-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 2, 2022
- Initiation Date
- December 27, 2021
- Termination Date
- September 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,8416/100 count bottles
Product Description
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.
Distribution Pattern
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
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