Clinicians advised to halt use of propofol from tainted lots

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Clinicians advised to halt use of propofol from tainted lots

Published Date:

7/9/09

Series:

HAN ; 296

Language:

English

[PDF-505.03 KB]

Details:

Corporate Authors:

Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration. ;

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:

[+]

Document Type:

HAN Health Advisory

Place as Subject:

United States

Collection(s):

Health Alert Network (HAN)

Main Document Checksum:

[+]

Supporting Files:

No Additional Files

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