D-0640-2021 Class II Terminated
FDA drug recall D-0640-2021 was initiated by VIONA PHARMACEUTICALS INC on June 1, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. The recall status is terminated (terminated May 31, 2023). Affected quantity: 21240 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 30, 2021
- Initiation Date
- June 1, 2021
- Termination Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21240 bottles
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
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution Pattern
Nationwide in the US
Code Information
Lot M915601 & M915602, Oct 2021