BETHESDA, MD 27 January 2012—Cephalon Inc. is recalling Treanda lot TB30111, containing bendamustine hydrochloride, because glass fragments were found in one of the vials, according to a press release circulated today by FDA.
The company said it distributed the vials to wholesalers and distributors between March 22 and October 5, 2011, and notified those recipients about the recall on November 18.
Hospitals and health care professionals in possession of vials in lot TB30111are instructed to stop using the vials and quarantine them for return.
According to the press release, the company had not received any report of an adverse event related to particulate matter in the vials.
The FDA-approved labeling for Treanda, which treats chronic lymphocytic leukemia, states that the product is manufactured by Pharmacehmie B.V., a Dutch subsidiary of Teva Pharmaceutical Industries Ltd.
Teva acquired Cephalon this past October.
A Teva spokeswoman said in an e-mail that the recall "should not have any impact on supply" of the leukemia drug; the company does not believe that much of lot TB30111 remains in stock.