Recalls / Class II
Class IID-0640-2021
Product
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
- 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
- Lot M915601 & M915602, Oct 2021
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, N/A, Cranford, New Jersey 07016-3617
Distribution
- Quantity
- 21240 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-06-01
- FDA classified
- 2021-06-24
- Posted by FDA
- 2021-06-30
- Terminated
- 2023-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0640-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.