Why it was recalled
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Product description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Lot numbers, UPCs & expiration 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
Where it was sold
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0392-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 27, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 23,8416/100 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VIONA PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0392-2022, exactly as published.
Show all FDA fields
- City
- Cranford
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89305
- Address
- 20 Commerce Dr Ste 340
- 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
- Postal code
- 07016-3617
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0392-2022
- Classification
- Class II
- Recalling firm
- VIONA PHARMACEUTICALS INC
- Product quantity
- 23,8416/100 count bottles
- Termination date
- Sep 20, 2023
- Reason for recall
- CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
- Distribution pattern
- Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
- Recall initiation date
- Dec 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 21, 2022