Glenmark Pharmaceuticals Inc. recalls 6,432 bottles of Carvedilol Tablets, USP, 12.5 mg, distributed nationwide in the United States. The recall concerns CGMP deviations and the presence of a nitrosamine impurity above the acceptable intake level. Consumers should stop taking the product and contact Glenmark for guidance.
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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 tablets are a beta-blocker used to treat high blood pressure and heart failure. They are prescribed by physicians and dispensed by pharmacies.
Nitrosamine impurities are potential carcinogens. Elevated levels in carvedilol could pose long-term health risks with chronic exposure.
This recall is not described as part of a broader industry pattern in the notice.
Immediate stop-use is required. Patients may need to switch therapies and manage supply through healthcare providers.
NDC on bottle label; lot code and expiry printed on the bottle
Refunds or replacement details will be provided via recall communications; expect weeks for processing
Keep copy of recall notice, bottle label, lot number, expiry, and any correspondence with the company
NDC 68462-164-05. 12.5 mg carvedilol tablets, 500-count bottles. Manufactured by Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa, India. Distributed by Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. Quantity: 6,432 bottles. Sold nationwide in the USA. Expiry seen on lot: 7/31/2026. Lot number: 19243202.
No specific patient injuries or adverse events are reported in the recall notice. The FDA enforcement listing indicates a high-hazard impurity concern.
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