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.
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 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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. Manufacturers distribute in tablet form to patients nationwide.
NNCI impurity above FDA limits could pose health risks; exact clinical implications depend on exposure and patient factors.
This recall is not described as part of a broader pattern in the provided data.
The recall requires patients and healthcare providers to review exposure, discontinue use where advised, and coordinate replacements or alternatives.
FDA recall page linked in enforcement report; manufacturer letters to healthcare providers
Processing and guidance to be provided via recall letters; replacements or refunds depend on provider and distributor timelines
Keep recall letters, patient exposure records, and communications with pharmacy or provider as documentation
Product: Carvedilol Tablets USP, 12.5 mg, 100-tablet carton. Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA. NDC 0904-7307-61. Lot: T05693. Expiration: 03/2026. Quantity: 26,628 cartons. Distribution: Nationwide in the United States.
No specific patient incidents or injuries are detailed in the recall notice. Hazard is chemical impurity risk; no incident counts provided.
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