Class II
Terminated
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
- Company
- Viona Pharmaceuticals Inc
- Recall Initiated
- June 1, 2021
- Posted
- June 30, 2021
- Recall Number
- D-0640-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 21240 bottles
- Firm Location
- Cranford, NJ, United States
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
Nationwide in the US
Lot / Code Info
Lot M915601 & M915602, Oct 2021
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