Subpotent, Impure Lots of Mitoxantrone Prompt Recall
Hospira announced a voluntary recall of 10 lots of Mitoxantrone after confirmation of subpotency and elevated impurity levels. A decreased potency can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity.
Mitoxantrone is indicated for use in acute nonlymphocytic leukemia (ANLL) in combination with other approved drugs; reduction of neurologic disability and/or frequency of clinical relapses in secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS); and treatment of pain in advanced hormone-refractory prostate cancer in combination with corticosteroids.
The full list of affected lots, including both human and veterinary Mitoxantrone, can be found here. The lots were distributed worldwide from February 2013 through November 2014. Hospira has implemented improvements for batches manufactured from March 2014.
Hospira has notified its direct customers via a recall letter and is arranging for affected lots to be returned.
For more information call (844) 265-7407 or visit FDA.gov.