Teva Pharmaceuticals' subsidiary Cephalon said Friday that it had issued a recall in November for one lot of the injectable leukemia drug Treanda because glass fragments were found in one vial of the drug.
In a statement, the company had received no reports of adverse events that could be attributed to the "particulate matter."
The concern was that particles could disrupt blood flow or damage tissues or organs.
Cephalon, based in Frazer, was bought by Teva in 2011. Teva is based in Israel, but has its Americas headquarters in North Wales and is building a facility in Northeast Philadelphia.
The drug is usually administered by injection in conjunction with other chemotherapy treatment. In a statement, Cephalon said it was recalling vials of "Treanda (bendamustine HCL) for Injection 25mg/8mL; lot TB30111" with an expiration date of "12/2012."
The drug is approved 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."
The lot recalled is packaged in 8 mL vials and was distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011. Cephalon says that recipients were previously notified on Nov. 18. The company says 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.
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David Sell covers the pharmaceutical industry and related topics for The Inquirer’s Business Department. David has been a reporter and editor for more than 20 years. Contact him with tips and suggestions about news from the drug industry and the people who define an industry that touches nearly everyone and employs tens of thousands in the Philadelphia area.
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