VIONA PHARMACEUTICALS INC: Drug Recall
Recall #D-0640-2021 · 06/01/2021
Class II: Risk
Recall Details
- Recall Number
- D-0640-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- VIONA PHARMACEUTICALS INC
- Status
- Terminated
- Date Initiated
- 06/01/2021
- Location
- Cranford, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21240 bottles
Reason for Recall
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
Distribution Pattern
Nationwide in the US
Other Recalls by VIONA PHARMACEUTICALS INC
- Class II: Risk 10/06/2025
- Class II: Risk 08/12/2025
- Class II: Risk 12/10/2024
- Class II: Risk 12/10/2024
- Class II: Risk 10/29/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.