Mitoxantrone Injection Recalled Due to Subpotency and Impurities

Hospira is voluntarily recalling 10 lots of human and veterinary Mitoxantrone injection due to confirmed subpotency and elevated impurity levels, according to the FDA.

The affected lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014. The lot numbers of the affected products in the US are Z054636AA, A014636AA, A024636AB, A014643AA, and A014645AA.

Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Customers who redistributed the recalled product should notify any accounts or additional locations that may have received the recalled product, and instruct them to notify any accounts, locations, or facilities to the consumer level about the recall.

The root cause has been investigated and found, and Hospira implemented improvements for batches manufactured from March 2014, the company said in a press release. The company has not received reports of any adverse events associated with subpotency and impurities for these lots, it stated.

Hospira notified its direct customers via a recall letter, and is arranging for impacted product to be returned to Stericycle in the US. For additional assistance in the US, call Stericycle at 1-844-265-7407 between 8 AM and 5 PM Eastern Time, Monday through Friday.

In addition to contacting their health care provider, patients who have experienced adverse reactions to this product should report them to the FDA's MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.