Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
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