Cephalon, Inc. is voluntarily recalling Treanda® (bendamustine HCL) for Injection 25mg/8mL; lot TB30111, expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.
Treanda® (bendamustine HCL) for Injection 25mg/8mL is indicated for the treatment of chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established. Treanda® (bendamustine HCL) for Injection 25mg/8mL is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab-containing regimen.
This recall is being conducted in consideration of the potential safety issue and risk associated with administration of this product lot. Potential adverse events after intravenous administration of solutions containing particulates may present as an emboli 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 macrovasular disease, such as cardiac and renal disease, who may be more at risk since their vasculature 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 should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Parenteral drugs products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permits as stated in the package insert.
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.
Recipients of the subject lot have been previously notified of this recall via overnight notification on 11/18/11 and are in the process of returning this product lot. Wholesalers, retailers, hospitals and health care professionals who have lot TB30111 in their possession are instructed to immediately cease using the product and immediately quarantine product for return. Consumers with questions regarding this recall may contact Genco at 877-319-8965 from 9:00am – 5:00pm CST Monday –Friday.
Adverse events that may be related to the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Online:www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
Consumers with questions regarding this recall may contact 877-319-8965 from 9:00am – 5:00pm CST Monday –Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
Cephalon, Inc. is voluntarily recalling the aforementioned product lot with the knowledge of the U.S. Food and Drug Administration.
