Glenmark Pharmaceuticals Inc. recalls 44,328 bottles of Carvedilol tablets, 3.125 mg, distributed nationwide in the USA. The impurity N-nitroso carvedilol I exceeds the Acceptable Intake Level. Consumers should stop using 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 is used to treat high blood pressure and heart failure. This 3.125 mg dose comes in standard Rx packaging.
Nitrosamines are potential carcinogens. The impurity exceeds acceptable intake levels, prompting CGMP deviations in manufacturing.
This recall is part of ongoing CGMP-related nitrosamine surveillance in regulated drug manufacturing.
The recall affects patients who rely on carvedilol for cardiovascular conditions, requiring them to stop use and seek medical guidance.
FDA recall page and Glenmark patient letters; label details on each bottle.
Refund/replacement timelines vary; check with Glenmark for specifics.
Retain recall notices, label copies, and pharmacy communications; document dates and contacts.
Product: Carvedilol Tablets, USP 3.125 mg. Packaging: 500-count bottle NDC 68462-162-05; 100-count bottle NDC 68462-162-01. Rx only. Manufactured by Glenmark Pharmaceuticals Ltd, Colvale-Bardez Goa, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA. Quantity: 44,328 bottles. Sold nationwide in the USA.
No specific injuries or incidents are reported in the dataset.
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