The US Food and Drug Administration (FDA) said in a statement that Cephalon distributed the Treanda lot TB30111 to wholesalers and distributors between March 22 and October 5, 2011, and notified those recipients about the recall on November 18. The FDA instructed hospitals and health care professionals in possession of vials in lot TB30111 to stop using them and quarantine them for return.
Cephalon said that it had not received any report of an adverse event related to particulate matter in the vials.
The FDA-approved labeling for Treanda states that the product is manufactured by Teva's Dutch subsidiary, Pharmacehmie BV. Teva acquired Cephalon in 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.
Teva's share price fell 2.6% by mid-afternoon on the TASE today to NIS 168.30, after falling 1.2% on Nasdaq on Friday to $44.91, giving a market cap of $39.7 billion.
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