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Belrapzo FDA Alerts

The FDA Alerts below may be specifically about Belrapzo or relate to a group or class of drugs which include Belrapzo.

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Belrapzo

Treanda (bendamustine HCL): Recall - Particulate Matter in Vial

ISSUE: Cephalon, Inc. notified healthcare professionals of a recall of 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. 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.

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.

BACKGROUND: Treanda (bendamustine HCL) for Injection 25mg/8mL 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.

RECOMMENDATION: Recipients of the subject lot have been previously notified of this recall via overnight notification on 11/18/11. 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[01/27/2012 - Press Release - Cephalon, Inc.]

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