Dissolution test failure behind voluntary recall of one lot of the thrombocytosis drug
Torrent Pharmaceuticals is voluntarily recalling one lot of Anagrelide capsules, USP, to the consumer level due to dissolution test failure detected during routine quality testing, according to the US Food and Drug Administration (USFDA).
Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when the body produces too many platelet cells.
Stating this, a communication from the regulator said 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, USFDA said.