Treanda Recall Issued Due to Particulate Matter Contamination

One lot of the leukemia drug Treanda has been recalled after glass fragments were found in a vial.

The Treanda recall was announced on January 27 by the FDA, which indicated that the fragments could cause an embolism and could disrupt blood flow, leading to tissue/organ damage.

The FDA cautioned that patients undergoing surgery, individuals with suppressed or compromised immune systems, the elderly and patients with micro or macrovascular disease, like heart disease and kidney disease, were most vulnerable to injury from glass fragments injected with the drug, which is delivered intravenously.

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There have been no injuries or adverse events reported in connection to the Treanda particulate matter contamination.

The recall affects 8 mL vials of Treanda (bendamustine), manufactured by Cephalon, Inc. The vials have a lot number of TB30111 and an expiration date of 12/2012. They were distributed to wholesalers and retailers nationwide from March 22, 2011 through October 5, 2011.

Treanda (bendamustine HCl) is an intravenous injection approved by the FDA in 2008 for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. It is manufactured by Cephalon and provides a reduced treatment time, as the infusion takes about an hour and can be done on an outpatient basis.

Side effects of Treanda have been linked to potentially fatal skin reactions known as Stevens-Johnson Syndrome and toxic epidermal necrolysis. At least one death has been reported after a user experienced the severe skin conditions from Treanda.

As a result of the particulate matter contamination, the FDA recommends that wholesalers, retailers and hospitals who have vials that belong to the affected lot in their possession immediately cease using them and quarantine the recalled Treanda for return. Known recipients of the recalled vials have been notified of the recall. Consumers with questions can call (877) 319-8965.

The FDA urges healthcare professionals and patients to report any adverse events or Treanda side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


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