Details:

Corporate Authors:
Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration.
Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. Less -
Description:
Monday, July 13, 2009, 19:00 EDT (7:00 PM EDT)

CDCHAN-00296-2009-07-13-ADV-N

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 byTeva 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.


Subject:
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Drug Contamination
Endoscopy, Gastrointestinal
Endotoxins
Propofol/administration & Dosage

Series:
HAN ; 296
Document Type:
HAN Health Advisory
Place as Subject:
United States
Collection(s):
Health Alert Network (HAN)
Main Document Checksum:
[+]
urn:sha256:95f4dd5f76177b78dfa76355c2b7056950da995fef9265dbbba5cb24bcd90339
File Type:

Supporting Files

• No Additional Files

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