The Lake Forest, Illinois company cites sub-potency and out-of-specification impurities
Hospira, a US manufacturer of injectable and biosimilar drugs, voluntary recalled 10 lots of Mitoxantrone at the end of 2014, a chemotherapy drug used to treat acute myeloid leukaemia, non-Hodgkin lymphoma, advanced breast and advanced primary liver cancer, for both human and veterinary use, due to 'confirmed subpotency and elevated impurity levels'.
The company said such out of specifications could potentially decrease potency, leading to decreased effectiveness, additional dosing and the potential for cumulative impurity toxicity requiring medical intervention.
The Lake Forest, Illinois-based company has not received reports of any adverse events associated with subpotency and impurities for these lots, which were distributed to hospitals and veterinary clinics in the US, Australia and New Zealand, the UK, Ireland, Cyprus, Saudi Arabia, Qatar, Oman and Bahrain from February 2013 to November 2014.
Hospira initiated an investigation to determine the root cause and corrective and preventive actions and appropriate improvements were initiated for batches manufactured from March 2014.
The company has notified its direct customers through a recall letter and is arranging for product affected to be returned to Stericycle in the US.