CDC STACKS serves as an archival repository of CDC-published products including scientific findings, journal articles, guidelines, recommendations, or other public health information authored or co-authored by CDC or funded partners.
As a repository, CDC STACKS retains documents in their original published format to ensure public access to scientific information.
i
Clinicians advised to halt use of propofol from tainted lots
-
07/09/2009
-
Source: HAN ; 296
-
Series: Health Alert Network
[PDF-505.03 KB]
Details:
-
Corporate Authors:
-
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 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.
-
Subjects:
-
Source:
-
Series:
-
Document Type:
-
Place as Subject:
-
Pages in Document:1 unnumbered page
-
Issue:296
-
Collection(s):
-
Main Document Checksum:
-
Download URL:
-
File Type: