D-0217-2025 Class II Terminated
FDA drug recall D-0217-2025 was initiated by RemedyRepack Inc. on January 24, 2025 and is designated Class II. Reason for recall: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. The recall status is terminated (terminated July 17, 2025). Affected quantity: 247 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2025
- Initiation Date
- January 24, 2025
- Termination Date
- July 17, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 247 blister packs
Product Description
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Reason for Recall
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Distribution Pattern
FL
Code Information
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.