Glenmark Pharmaceuticals recalls 14,976 bottles of Carvedilol 25 mg distributed nationwide in the United States after FDA-identified NNCI impurity exceeds limits. The impurity prompted CGMP deviation findings. Consumers should stop taking the drug and contact Glenmark or a healthcare provider for guidance.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter
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Carvedilol is a beta-blocker used to treat high blood pressure and heart failure. Consumers may be prescribed or dispense it as a generic or brand medication.
Nanogram-level nitrosamines like NNCI are suspected to be carcinogenic with long-term exposure. FDA limits set 4.0 ppm for this impurity.
This recall is not part of a broader industry pattern.
Low immediate safety risk but potential long-term cancer risk with chronic exposure. Affects patients currently taking carvedilol with this lot.
Label on carton and bottle shows NDC, lot, and expiration. FDA recall page provides details.
Recall notices by letter; refunds or replacements processed per company policy within 4-8 weeks.
Keep recall letter, FDA notice, purchase proof, bottle label, and any correspondence.
Brand: CARVEDILOL. Product: Carvedilol Tablets, USP, 25 mg, 500 tablets per carton. Manufactured by Glenmark Pharmaceuticals Ltd., India. Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430. NDC: 68462-165-05. Lot numbers: 17241213, 17241215, 17241224. Expiration: 06/2026. Quantity: 14,976 bottles. Distribution: Nationwide in the USA.
No specific injuries or adverse events are detailed in the recall notice.
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The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.
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