Credit: Bill Branson
Hospira, Inc. has initiated a worldwide, user-level recall of 10 lots of Mitoxantrone (both human and veterinary) due to confirmed subpotency and elevated impurity levels.
Drugs in the affected lots may exhibit decreased effectiveness, require additional dosing, or prompt cumulative impurity toxicity requiring medical intervention.
However, Hospira has not received reports of any adverse events associated with subpotency and impurities for these lots to date.
The lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014.
The following lots are affected by the recall. (To ensure this list displays properly, click the “Hide” icon on the right side of this page to hide the “In this Section” column.)
United States
Product NDC Number Lot Expiration Date
MitoXANTRONE Injection, USP, 61703-343-18 Z054636AA December 2014
(concentrate) 20 mg/10 mL, A014636AA April 2015
2 mg/mL in 10 mL, 10 mL Vial, A024636AB July 2015
Multi Dose Vial
MitoXANTRONE Injection, USP, 61703-343-65 A014643AA April 2015
(concentrate) 25 mg/12.5 mL,
2 mg/mL in 12.5 mL, 12.5 mL Vial,
Multi Dose Vial
MitoXANTRONE Injection, USP, 61703-343-66 A014645AA November 2015
(concentrate) 30 mg/15 mL,
2 mg/mL in 15 mL, 15 mL Vial,
Multi Dose Vial
Australia and New Zealand
Product Product Code Batch Number Expiration Date
DBL™ MitoXANTRONE M4636A A024636AA July 2015
Hydrochloride Injection
(concentrate) 20mg/10mL
Injection Vial
United Kingdom, Ireland, Cyprus, Saudi Arabia, Qatar, Oman and Bahrain
Product List Number Lot Expiration Date
MitoXANTRONE 2 mg/mL; M4636AGB1 A014636AB April 2015
Concentrate for Infusion A024636AD July 2015
Z054636AB Dec 2014
Canada
Product List Number DIN Lot Expiration Date
MitoXANTRONE for
Injection 20mg /10mL USP 4636A001 02244614 A024636AC July 2015
Anyone with an existing inventory of the recalled lots should stop use and distribution, and quarantine the product immediately. This recall is being carried out to the user level (both human and veterinary).
Hospira has 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 the hours of 8 am and 5 pm ET, Monday through Friday. Customers outside the US should work with their local Hospira offices to return the product per local recall notifications.
For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week).
To report adverse events or for product complaints, contact Hospira Global Complaint Management at 1-800-441-4100 (M-F, 8 am to 5 pm CT).
Adverse events or quality problems associated with Mitoxantrone can also be reported to the FDA’s MedWatch Adverse Event Reporting Program.
