This is an official
CDC HEALTH ADVISORY
Distributed via Health Alert Network
Monday, July 13, 2009, 19:00 EDT (7:00 PM EDT)
CDCHAN-00296-2009-07-13-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.
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