Drug recall D-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
Reason for recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Lots and codes
Lot M915601 & M915602, Oct 2021
Recall details
- Recalling firm
- VIONA PHARMACEUTICALS INC, Cranford, NJ
- Quantity
- 21240 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 1, 2021
- Terminated
- May 31, 2023
Related products
- Metformin hydrochloride – drug information
- NDC 72578-036 Metformin Hydrochloride · Metformin Hydrochloride 750 mg/1 · Viona Pharmaceuticals Inc
- NDC 72578-035 Metformin Hydrochloride · Metformin Hydrochloride 500 mg/1 · Viona Pharmaceuticals Inc