Recalls / Class II
Class IID-0392-2022
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
- Brand name
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 72578-035, 72578-036
- FDA application
- ANDA077060
- Affected 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
Why it was recalled
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recalling firm
- Firm
- VIONA PHARMACEUTICALS INC
- Manufacturer
- Viona Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Commerce Dr Ste 340, Cranford, New Jersey 07016-3617
Distribution
- Quantity
- 23,8416/100 count bottles
- Distribution pattern
- Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Timeline
- Recall initiated
- 2021-12-27
- FDA classified
- 2022-01-21
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0392-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.