Clinicians Advised to Halt Use of Propofol from Tainted Lots [Monday, July 13, 2009, 19:00 EDT (7:00 PM EDT)]

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.). Health Alert Network (HAN)
• 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.
  
  
• Content Notes:
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  Health Alert: Requires immediate action or attention, highest level of importance.
  
  Health Advisory: May not require immediate action; provides important information for a specific incident or situation.
  
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• Subjects:
  Drug Contamination Endoscopy, Gastrointestinal Endotoxins Propofol/administration & Dosage
• Keywords:
  HAN Health Alert Network
• Source:
  HAN ; 296
• Series:
  Health Alert Network
• Subseries:
  CDC Health Advisory
• Publisher:
  Centers for Disease Control and Prevention (CDC) (U.S.)
• Document Type:
  Text
• Genre:
  Alert
• Place as Subject:
  United States
• Rights:
  Public Domain
• Pages in Document:
  1 unnumbered page
• Issue:
  00296
• Collection(s):
  Health Alert Network (HAN)
• Main Document Checksum:
  urn:sha-512:d762cbdd29ca97c795444e21f11e7cd49f6a0ca61ae6a16384e89edebe11b31a2e60475289c8b28f891167f04c6d63824a446714bb99e876d4acba57dd4544c3
• Download URL:
  https://stacks.cdc.gov/view/cdc/25207/cdc_25207_DS1.pdf
• File Type:
  [PDF - 505.03 KB ]