Recalls

Lots of tainted leukemia, lymphoma medication recalled

Some vials of Treanda (bendamustine HCL) for Injection 25mg/8mL, a medication used to treat chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL), is being recalled because a single vial was found to contain tiny glass fragments.

If patients are injected with this tainted medication, the glass fragments may create a block in the blood vessels and result in disruption of blood flow causing tissue and/or organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly. Also at risk are patients with micro or macrovasular disease, such as cardiac and renal disease, whose blood vessels and end organs are already compromised.

To date, Cephalon, Inc. has not received any adverse events associated with the use of this product lot that could be attributed to particulate matter.

Treanda for Injection is administered by a qualified physician experienced in use of cancer chemotherpeautic agents. Appropriate management of therapy and complications is only possible when diagnostic and treatment facilities are readily available. Medical staff are trained to visually inspect parenteral drugs for particulate matter and discoloration prior to administration of any solution.

The affected medication involves lot TB30111 with the expiration date 12/2012. The products were distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011. Recipients of the affected lot of Treanda have been instructed to return the medication to the manufacturer.

Any adverse events with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/GetForms.htm.

Source: FDA