Certain Lots of Teva Propofol Recalled

Teva Pharmaceuticals is recalling certain lots of Propofol Injectable Emulsion 10 mg/mL because some of the vials in these lots contain elevated endotoxin levels.

The company says that it has received over 40 reports of patients treated with propofol who experienced fever, chills and other flu-like symptoms post-operatively. Based on available information, these febrile or flu-like reactions were self-limited and spontaneously resolved. However, patients exposed to high endotoxin levels could experience serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death.

The recall affects lot numbers 31305429B and 31305430B, which contain 100 mL vials. Anyone with propofol from these lots should not use it and return it to the distributor. For more information, contact Teva Pharmaceuticals at 1-866-262-1243.

FDA Patient Safety News: October 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=91#3

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Tags:

• Propofol
• anesthesia
• endotoxin
• Teva Pharmaceuticals
• adverse effect
• drug
• FDA