Recalls / Class II
Class IID-0217-2025
Product
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.
- Affected lot / code info
- Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
Why it was recalled
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 247 blister packs
- Distribution pattern
- FL
Timeline
- Recall initiated
- 2025-01-24
- FDA classified
- 2025-02-03
- Posted by FDA
- 2025-02-12
- Terminated
- 2025-07-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0217-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.