Propofol Recalled Due To Potential Endotoxin Contamination

Posted on August 1, 2009

The fast acting anesthetic, propofol was recently linked to 41 cases of human illness due to suspected endotoxin contamination according to the FDA.  Teva Pharmaceuticals has recalled the potentially contaminated product.  The symptoms seen were post-operative fever, chills and other flu-like symptoms. Apparently, all reactions were self-limiting and spontaneously resolved. 

The recall involves only 100 ml vials, lots 31305429B and 31305430B. Most veterinary practices only use smaller 20 ml vials of propofol due to smaller doses used and a short window for use once opened.  It is known that the emulsion used for propofol supports bacterial growth.  Propofol is a hydrophobic, water-insoluble oil and to make it soluble, it is put into an “oil in water” emulsion that includes soybean oil, glycerol and egg lecithin.  This emulsion has a high nutrient content and can serve as a growth medium for microbes.  This recall is a good reminder of the importance of maintaining aseptic conditions when administering propofol and the contents should be administered within 6 hours of aspirating from the vial at maximum.