Safety Alerts & Recalls

What does this mean?

Treanda is administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Any patient previously exposed to the recalled product would have been under close supervision and their physician would have provided the needed management of therapy and complications associated with Treanda. Possible adverse events after intravenous administration of solutions containing glass fragments may present as a blood clot and result in disruption of blood flow causing tissue/organ damage.

In November 2011, wholesalers, retailers, hospitals and health care professionals who have lot TB30111 in their possession were instructed to immediately stop using this specific lot number. This recalled lot number was not given to patients after this time.

You should contact your physician or healthcare provider if you or someone you care for has experienced any problems that may be related to taking Treanda. Consumers with questions regarding this recall may contact Cephalon, Inc. at 877-319-8965 from 9:00am – 5:00pm CST Monday –Friday.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Treanda (bendamustine HCL) Recall - Particles Found in Vial

Cephalon, Inc. is voluntarily recalling Treanda (bendamustine HCL) for Injection 25mg/8mL, lot TB30111, expiration date 12/2012. This product lot is being recalled because glass fragments were found in a single vial from this lot.

To date, Cephalon, Inc. has not received any adverse event reports associated with the use of this product lot that could be attributed to the glass fragments.

Treanda is indicated for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).

For more information, please visit: more information here

Source: FDA
Publication Date: 2012-01-30
Last Updated: 2012-01-30

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