RemedyRepack Inc.: Drug Recall
Recall #D-0217-2025 · 01/24/2025
Class II: Risk
Recall Details
- Recall Number
- D-0217-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- RemedyRepack Inc.
- Status
- Terminated
- Date Initiated
- 01/24/2025
- Location
- Indiana, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- 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.
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.
Distribution Pattern
FL
Other Recalls by RemedyRepack Inc.
- Class II: Risk 04/22/2025
- Class II: Risk 03/24/2025
- Class II: Risk 12/02/2024
- Class II: Risk 06/26/2024
- Class II: Risk 05/31/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.