Reported Feb 12, 2025 · Terminated
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ…
RemedyRepack Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RemedyRepack Inc. · 625 Kolter Dr Ste 4 · Indiana, PA · 15701-3571
Is this the product you have?
- Carvedilol 25 mg Tablet
- QTY30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only
- MFG byGlenmark, Mahwah, NJ 07430
- Repackaged byRemedyRepack Inc., Indiana, PA 15701
- NDC70518-3945-00
- Lot codes and dates
Lot #s: J0777493050824Exp. 5/31/2025J0787856062124Exp. 7/31/2025
- Amount recalled
- 247 blister packs
Where it was sold
Why it was recalled
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
This product could cause temporary or reversible health problems — stop using it.
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