D-0441-2023 Class II Terminated
FDA drug recall D-0441-2023 was initiated by Teva Pharmaceuticals USA Inc on February 22, 2023 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 December 6, 2023). Affected quantity: 12,044 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2023
- Initiation Date
- February 22, 2023
- Termination Date
- December 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,044 Bottles
Product Description
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution Pattern
CA
Code Information
Lot #: 1410946A; Exp. 06/2023