FDA Drug Worldwide Recall Notification: Drug Confirmed Subpotency and Out-of-Specifications-Impurities



FOR IMMEDIATE RELEASE – December 23, 2014 – LAKE FOREST, Ill. – Hospira, Inc. (NYSE: HSP), announced today it has initiated a voluntary recall of 10 lots, identified below, of MitoXANTRONE (both human and veterinary), due to confirmed subpotency and elevated impurity levels.


Risk factors associated with these types of out of specifications may include the potential for decreased potency which can lead to decreased effectiveness, additional dosing and the potential for cumulative impurity toxicity requiring medical intervention. To date, Hospira has not received reports of any adverse events associated with subpotency and impurities for these lots.

These lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014. The lot numbers affected by the recall are:

United States

Product NDC Number Lot Expiration Date
MitoXANTRONE Injection, USP, (concentrate) 20 mg/10 mL, 2 mg/mL in 10 mL, 10 mL Vial, Multi Dose Vial 61703-343-18 Z054636AA December 2014
A014636AA April 2015
A024636AB July 2015
MitoXANTRONE Injection, USP, (concentrate) 25 mg/12.5 mL, 2 mg/mL in 12.5 mL, 12.5 mL Vial, Multi Dose Vial 61703-343-65 A014643AA April 2015
MitoXANTRONE Injection, USP, (concentrate) 30 mg/15 mL, 2 mg/mL in 15 mL, 15 mL Vial, Multi Dose Vial 61703-343-66 A014645AA November 2015

Australia and New Zealand

Product Product Code Batch Number Expiration Date
DBL™ MitoXANTRONE Hydrochloride Injection (concentrate) 20mg/10mL Injection Vial M4636A A024636AA July 2015


Product List Number DIN Lot Expiration Date
MitoXANTRONE for Injection 20mg /10mL USP 4636A001 02244614 A024636AC July 2015

United Kingdom, Ireland, Cyprus, Saudi Arabia, Qatar, Oman and Bahrain

Product List Number Lot ExpirationDate
MitoXANTRONE 2 mg/mL; Concentrate for Infusion M4636AGB1 A014636AB April 2015
A024636AD July 2015
Z054636AB Dec 2014

Hospira initiated an investigation to determine the root cause and corrective and preventive actions. The root cause was subsequently found and appropriate implementations of improvements have been initiated for batches manufactured from March 2014.

Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. This recall is being carried out to the user level (both human and veterinary). Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the consumer level. Hospira has notified its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance in the U.S., call Stericycle at 1-844-265-7407 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. Customers outside the United States should work with their local Hospira offices to return the product per local recall notifications.


For clinical inquiries, please contact Hospira using the information provided below.

Hospira Contact Contact Information Areas of Support
Hospira Global Complaint Management 1-800-441-4100 (M-F, 8 a.m. to 5 p.m. CT) (ProductComplaintsPP@hospira.com) To report adverse events or product complaints
Hospira Medical Communications 1-800-615-0187 OR medcom@hospira.com(Available 24 hours a day/7 days per week) Medical inquiries

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.


This recall is being conducted with the knowledge of the U.S. Food and Drug Administration, and relevant regulatory agencies outside the United States, including the Therapeutic Goods Administration, Health Canada and Medicines and Healthcare Products Regulatory Agency.

About Hospira
Hospira, Inc. is the world’s leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 19,000 employees. Learn more at www.hospira.com.


2014 The NW Fire Blog