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 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
Lot numbers, UPCs & expiration codes
Lot M915601 & M915602, Oct 2021
Where it was sold
Nationwide in the US
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-0640-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 1, 2021
- FDA report date
- Jun 30, 2021
- Quantity
- 21240 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VIONA PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0640-2021, exactly as published.
Show all FDA fields
- City
- Cranford
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88033
- Address
- 20 Commerce Dr Ste 340
- Code information
- Lot M915601 & M915602, Oct 2021
- Postal code
- 07016-3617
- Report date
- Jun 30, 2021
- Product type
- Drugs
- Recall number
- D-0640-2021
- Classification
- Class II
- Recalling firm
- VIONA PHARMACEUTICALS INC
- Product quantity
- 21240 bottles
- Termination date
- May 31, 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 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jun 1, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2021