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Recall of Treanda for Injection Due to Possible Contamination

Cephalon has issued a recall for Treanda (bendamustine HCL). The recall affects the 25mg/8mL, and is marked as lot TB30111 with an expiration date of 12/2012. The recall was made after the presence of particulate matter found was found in a single vial which has since been identified as glass fragments.

Indicated for the treatment of chronic lymphocytic leukemia (CLL), the affected Treanda lot is packaged in 8 mL vials and was distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011.

The recall has been made in consideration of the potential safety issue and risk associated with the administration of this product lot. Potential adverse effects after the administration of solutions containing particulates may present as an embolus and result in disruption of blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly, as well as patients with micro- or macrovascular disease, such as cardiac and renal disease, who may be more at risk since their vasculature and end organs are already compromised. Treanda provides a reduced treatment time, as the infusion takes about an hour and can be done on an outpatient basis. Side effects of Treanda have been linked to potentially fatal skin reactions known as Stevens-Johnson Syndrome and toxic epidermal necrolysis. At least one death has been reported after a user experienced severe skin conditions from Treanda.

To date, Cephalon says it has received no injury reports.