IGMPI India



Recall of Class 2 Medicines(Mitoxantrone 2mg/ml Concentrate) for Solution

Hospira UK limited has recalled a number of batches of Mitoxanthrone due to a number of confirmed out of specification test results obtained during stability studies.The batches were recalled due to adverse impurity profile and low potency.

The recalled batch numberalong with their details are provided in the table below:

Batch Number Expiry Date Pack Size First Distributed
Z054636AB Dec 2014 1 x 10ml 18 Feb 2013
A014636AB Apr 2015 1 x 10ml 14 Oct 2013
A024636AD Jul 2015 1 x 10ml 31 Mar 2014
Remaining stock of the affected batches would be quarantined and customers who have already received the affected batches are being contacted to arrange for collection of the same through their primary wholesaler.