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Drug Safety Alerts
Torrent Pharmaceuticals Limited Anagrelide 1 mg Capsules Consumer-Level Recall
12/09/2020
On December 9, 2020, the United States Food and Drug Administration (FDA) published a consumer-level recall of Anagrelide 1 mg capsules NDC #13668-0462-01 manufactured by Torrent Pharmaceuticals Limited. This recall is due to dissolution test failure detected during routine quality testing of stability.
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 heart attack or stroke which could be life-threatening. Torrent Pharmaceuticals Limited advises that, to date, it has not received any reports of adverse events related to this recall.
This may represent a potential health hazard or safety risk to patients using product affected by this recall.
This recall affects lot BFD1G001 exp. 12/2021.
Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelet cells.
As the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment, the manufacturer has advised that patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
CVS Caremark Response: Because of this action, CVS Caremark® is sending letters to members who received this product through CVS Caremark® Mail Service Pharmacy and their physicians
For more information, call Torrent Pharmaceuticals Limited toll-free at 1-800-912-9561 (live calls received Monday-Friday, 8:00 AM – 5:00 PM (EST), voicemail available Monday-Friday, 8:00 AM – 5:00 PM (EST). You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at https://www.fda.gov.