Bendamustine Hydrochloride (Treanda®)
January 30, 2012
Cephalon has voluntarily recalled bendamustine hydrochloride (Treanda®) 25 mg/8mL vials, lot TB30111, expiration date 12/2012. The affected lot was distributed between March 22, 2011 and October 5, 2011. The lot is being recalled because glass fragments were found in a single vial. Serious adverse events or death are possible if particulate matter is injected intravenously. As of January 27, 2012, no adverse events have been reported as a result of the affected lot.
Stop using the affected product immediately. Quarantine and return the affected lot. Cephalon initially notified recipients of the recall and arranged for returns in November, 2011. Contact Genco at 877-319-8956 with any questions regarding this recall.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm).
Additional information is available at the following links:
January 30, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.