After Warning Letter, a recall for Hospira injectables
Mitoxantrone is an anthracenedione antineoplastic agent used in oncology. Affected batches were manufactured from March 2014 onwards.
Injectables with decreased potency can lead to decreased effectiveness, additional dosing and the potential for cumulative impurity toxicity requiring medical intervention, the company said.
The drug was distributed for human and veterinary use in North America, Australia, New Zealand, the UK, Ireland, Cyprus, and the Middle East.
Hospira said it has identified the root cause of the batch faults.
Plant problems
Mitoxantrone is manufactured at Hospira’s site in Mulgrave Australia. The plant received a Warning Letter from the FDA in September 2014 because of unknown impurity levels in batches of the cancer drug.
The FDA wrote Hospira had “failed to thoroughly investigate unexplained discrepancies or failures of a batch” after stability studies on several batched of Mitoxantrone injections showed impurities.
The regulator added it was “concerned that you do not know the actual levels of this impurity in distributed lots of Mitoxantrone Injection.”
The drugmaker did not tell in-Pharmatechnologist.com the reason for a delay between the Warning Letter on September 26 and the launch of the Mitoxantrone recall on December 23.
The voluntary recall affects the following lots:
US
MitoXANTRONE Injection, USP, (concentrate) 20 mg/10 mL, 2 mg/mL in 10 mL, 10 mL Vial, Multi Dose Vial, Lots Z054636AA, A014636AA, and A024636AB;
Australia and New Zealand
MitoXANTRONE Injection, USP, (concentrate) 25 mg/12.5 mL, 2 mg/mL in 12.5 mL, 12.5 mL Vial, Multi Dose Vial, Lot A014643AA;
Canada
MitoXANTRONE for Injection 20mg /10mL USP, Lot A024636AC;
UK, Ireland, Cyprus, Saudi Arabia, Qatar, Oman and Bahrain
MitoXANTRONE 2 mg/mL; Concentrate for Infusion, Lot A014636AB, A024636AD, and Z054636AB.
