Mitoxantrone 2 mg/mL Injection Vials from Hospira - Voluntary Recall Due to Reduced Potency and Increased Impurity
December 26, 2014
Hospira is recalling 10 lots of Mitoxantrone 2 mg/mL Injection vials that were found to have reduced potency and increased impurity levels. The recalled vials were distributed between February 2013 and November 2014 to hospitals and veterinary clinics. Refer to the company press release for specific information on lots distributed in Canada (1 lot); Australia and New Zealand (1 lot); and, the United Kingdom and Middle East (3 lots). The following 5 lots are affected in the US:
- Mitoxantrone 2 mg/mL injection, in 10 mL multiple-dose vial (NDC 61703-343-18): Lot Z054636AA (expiry December 2014), Lot A014636AA (expiry April 2015), Lot A024636AB (expiry July 2015).
- Mitoxantrone 2 mg/mL injection, in 12.5 mL multiple-dose vial (NDC 61703-343-65): Lot A014643AA (expiry April 2015).
- Mitoxantrone 2 mg/mL injection, in 15 mL multiple-dose vial (NDC 61703-343-66): Lot A014645AA (expiry November 2015).
Mitoxantrone is an antineoplastic agent used in both humans and animals. Decreased mitoxantrone potency may result in reduced efficacy, while high impurity levels may lead to toxicity. To date, Hospira has not received any reports of adverse events associated with these products. Hospira has investigated this defect and has corrected the root cause.
Healthcare facilities are advised to discontinue use of affected mitoxantrone and quarantine the product until it can be returned. For clinical questions about this defect, please contact Hospira Global Complaint Management at 1-800-441-4100 (Monday to Friday, from 8 AM to 5 PM Central Standard Time) about adverse events, or Hospira Medical Communications at 1-800-615-0187 (24 hours a day, 7 days a week) about medical inquiries. Hospira has arranged for US customers to return product through Stericycle. For questions regarding returns, please contact Stericycle at 1-844-265-7407, Monday to Friday, from 8 AM to 5 PM Eastern Standard Time. Report any adverse events associated with the use of mitoxantrone to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Additional information is available at the following links:
- MedWatch Alert:
- Company press release:
December 26, 2014; University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.