Status
Terminated
Drug Enforcement D-0217-2025
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Classification
Class II
Report Date
February 12, 2025
Termination Date
July 17, 2025
Product Information
- 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.
- Product quantity
- 247 blister packs
- Reason for recall
- CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- FL
Location & Firm
- Recalling firm
- RemedyRepack Inc.
- Address
-
625 Kolter Dr Ste 4
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0217-2025
- Event ID
- 96191
- Recall initiation date
- January 24, 2025
- Center classification date
- February 3, 2025
- Code info
- Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
- More code info
- —