August 4, 2009
Propofol recall expanded
Three additional lots affected
By: Jennifer Fiala
For The VIN News Service
Three additional lots of Teva Pharmaceutical's injectable propofol have been recalled as a precautionary measure.
According to a letter to customers, the class 1 recall's expansion includes 100-ml vials in lot 31305324B, 20-ml vials in lot 31305323B and 50-ml vials in lot 31305431B.
Teva spokeswoman Denise Bradley did not respond to VIN News Service (VNS) media requests by press time. Laura Alvey, deputy director of communications with FDA's Center for Veterinary Medicine, explains that recalls are voluntary, and the agency merely monitors them. FDA does not recall products.
"I can confirm that the company recalled additional lots of propofol related to the initial recall of July 16," Alvey writes in an e-mail to VNS.
Earlier this month, Israeli-based Teva Pharmaceuticals voluntarily recalled 57,000 bottles of injectable propofol after lots 31305429B and 31305430B were found to be contaminated with endotoxin bacteria. Investigations by the Centers for Disease Control and Prevention (CDC) as well as FDA show that the originally recalled propofol was packaged in 100-ml vials. A CDC advisory urged clinicians to stop using the recalled anesthetic.
The newly recalled lots have not tested positive for elevated endotoxins.
Teva advises customers to examine their inventory for the affected lots, which shipped between Feb. 3, 2009, and March 24, 2009, and immediately discontinue the use of any recalled product. Company officials ask that all customers complete and fax a recall stock response form to Teva, even if no recalled product is found.
Upon receipt of the recall response form, Teva promises to credit customers for recalled product, including handling and shipping expenses.
Teva's expanded recall comes on the heels of an unrelated crackdown by FDA on the company's animal-health subsidiary, based in Missouri. Teva Animal Health has been forced to stop manufacturing generics and its DVM Pharmaceuticals line of products while it attempts to beef up its quality control practices to meet FDA standards.
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