Indiana Health Alert Network

This is an Official
Indiana Health Alert Network Advisory Message

Distributed via the Indiana Health Alert Network
7/13/2009 7:17:51 PM
IHAN-641-2009-7-13

Urgency Type: Advisory
Message Status: Actual
Message Type: Original

Clinicians Advised to Halt Use of Propofol from Tainted Lots

This is an official
CDC Health Advisory

Distributed via Health Alert Network
July 13, 2009, 19:00 ET (7:00 PM ET)
CDCHAN-00296-09-07-13-ADV-N

Clinicians Advised to Halt Use of Propofol from Tainted Lots

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have been investigating recent cases of febrile reactions among patients undergoing endoscopy in the United States.

This investigation has revealed that all of the case-patients received the anesthetic propofol from 100 ml vials manufactured by Teva Pharmaceuticals.

Testing done by the FDA has found that two lots of this product that were in use in facilities reporting febrile 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 Pharmaceuticals are continuing to investigate this issue.

To date, all case-patients have recovered.

As additional information about the recall becomes available, an updated Health Alert Notice will be provided.