Hospira 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:
|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|
|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
|MitoXANTRONE 2 mg/mL; Concentrate for Infusion||M4636AGB1||A014636AB||April 2015|
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 firstname.lastname@example.org (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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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.