Hospira Recalls 10 Lots of MitoxantroneBy
Hospira, Inc. has initiated a voluntary recall of 10 lots of mitoxantrone due to confirmed subpotency and elevated impurity levels. The company announced the recall on December 23, 2014. Mitoxantrone is an antineoplastic used to treat multiple sclerosis and certain types of cancer.
The affected lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014 in the United States, Australia, New Zealand, Canada, United Kingdom, Ireland, Cyprus, Saudi Arabia, Qatar, Oman and Bahrain. 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.
To date, Hospira has not received reports of any adverse events associated with subpotency and impurities for these lots. 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.
Source: FDA and Hospira