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Parsippany, NJ. Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.
Administration of this product with lower dissolution – taking longer to dissolve once ingested -- may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life threatening. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot.
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