January 30, 2012
RECALL: Treanda Recalled Due to Particulate Matter in VialCephalon and the FDA have notified healthcare professionals of a voluntary recall of one lot of Treanda (bendamustine HCl) for injection 25mg/8mL. Lot TB30111, expiry date of 12/2012, is being recalled due to the presence of glass fragments found in a single vial. The affected lot was distributed to wholesalers and distributors between March 22, 2011 and October 5, 2011. Healthcare providers who have the affected product in their possession should stop using it immediately and quarantine the product for return.
Treanda is indicated for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab-containing regimen.
For more information visit www.fda.gov/Safety/Recalls/ucm289452.htm.