FDAHealthJanuary 24, 2025
RemedyRepack Inc. — 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,
⚠️ CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Is this relevant to me?
- Geography
- FL
- Source agency
- FDA
- Category
- Health
- Published
- January 24, 2025
FL
What's affected?
- 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.
- Brand
- RemedyRepack Inc.
- Lot code
- J0777493050824
Additional details
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 247 blister packs.
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