  |
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
AUDIENCE: Oncology, Pharmacy, Nursing, Risk Manager
ISSUE: Hospira, Inc. announced today it has initiated a worldwide voluntary recall to the user level of 10 lots 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.
BACKGROUND: Affected lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014. See Firm Press Release for affected product information. 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.
RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. 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 8a.m. to 5 p.m. ET, Monday through Friday.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online:
- Download form 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
Read the MedWatch Safety Alert, including links to the Firm Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm427967.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
