Hospira, Inc., is initiating a worldwide recall of 10 lots of MitoXANTRONE (both human and veterinary) because the medication was found to be sub-potent with elevated impurity levels, which could lead to decreased effectiveness, additional dosing and the potential for cumulative impurity toxicity requiring medical intervention.
MitoXANTRONE is used to treat certain types of cancer, mostly metastatic breast cancer, acute myeloid leukemia, and non-Hodgkin’s lymphoma. It is also used to treat children suffering from first relapse of acute lymphoblastic leukemia, in combination with prednisone as a second-line treatment for metastatic hormone-refractory prostate cancer, and to treat multiple sclerosis (MS), in particular secondary progressive MS.
Affected lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014. The root cause was found and Hospira says appropriate implementations of improvements have been initiated for batches manufactured from March 2014.
Hospira has contacted customers who have received the sub-potent and impure products and told to stop using them and quarantine them immediately.
This is the latest in a string of recalls issued this year by Hospira, mostly for injectable solutions contaminated with glass particles and human hair, but also for malfunctioning infusion pumps.
Patients who have experienced any side effects related to this recall should report the matter to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.