FDA MedWatch - Anagrelide Capsules by Torrent Pharmaceuticals: Recall - Due to Dissolution Test Failure

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Anagrelide Capsules by Torrent Pharmaceuticals: Recall - Due to Dissolution Test Failure AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy  ISSUE: Torrent Pharmaceuticals Limited is recalling one lot of Anagrelide Capsules, due to dissolution test failure detected during routine quality testing. 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 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, Torrent Pharmaceuticals has not received any reports of adverse events related to this recall. For product photos, product description, NDC and lot numbers click the red button "Read Recall" below.  BACKGROUND: Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelet cells. RECOMMENDATION: The risk of harm to the patient's health may be higher if treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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