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CDC Health Alert Network (HAN) Info Service Message: Clinicians Advised to Halt Use of Propofol from Tainted Lots

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

Summary

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.

Categories of Health Alert messages:

Health Alert conveys the highest level of importance; warrants immediate action or attention.
Health Advisory provides important information for a specific incident or situation; may not require immediate action.
Health Update provides updated information regarding an incident or situation; unlikely to
require immediate action.

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

This Message was distributed to State and Local Health Officers, Public Information Officers, Laboratory Directors, Weapons of Mass Destruction Coordinators, Epidemiologists and HAN Coordinators as well as Association and Clinician organizations.

The HAN Info Service is utilized by the CDC's Health Alert Network to distribute general correspondence from CDC which is not necessarily considered to be of an emergent nature.