July 15, 2009
Tainted lots of propofol prompt recall
CDC, FDA urge clinicians to check inventory
By: Jennifer Fiala
For The VIN News Service
Two lots of Teva Pharmaceuticals' anesthetic propofol were voluntarily recalled following a federal government investigation of recent cases of nonrespiratory febrile reactions among human patients undergoing endoscopy in the United States.
Investigations by the Centers for Disease Control and Prevention (CDC) as well as the Food and Drug Administration (FDA) show that all of the propofol used in these cases came from 100-ml vials manufactured by Teva Pharmaceuticals. Clinicians are urged to stop using propofol from lots 31305429B and 31305430B, according to a CDC advisory issued on July 13.
The anesthetic recalled tested positive for elevated levels of endotoxin, federal investigators say. There have been no fatalities in connection with the tainted product.
Any adverse events that might be related to the use of propofol should be reported to the FDA. An updated Health Alert Notice will accompany any additional information as the agencies continue the investigation.
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