July 14, 2009

Propofol Recall

CDC is investigating recent febrile reactions among patients undergoing endoscopy in the United States. This investigation has revealed that all affected patients received the anesthetic propofol from 100 mL vials manufactured by Teva Pharmaceutical Industries. Testing conducted by FDA revealed that two lots of this product used in facilities reporting reactions were positive for elevated levels of endotoxin. The lots are 31305429B and 31305430B. Teva Pharmaceuticals is initiating a voluntary recall for these lots, and clinicians are advised to immediately stop using these lots of Teva Pharmaceuticals propofol. CDC, FDA, and Teva Pharmaceutical Industries are continuing to investigate this issue.  To date, all case-patients have recovered.