Teva Pharmaceuticals USA, a generic pharmaceutical company, issued a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials because of elevated endotoxin levels in certain lots.
The lot numbers being recalled are 31305429B and 31305430B.
Teva was recently notified of 41 propofol-treated human patients who experienced postoperative fever, chills and other flu-like symptoms. Testing done by the U.S. Food and Drug Administration found that the two lots used in facilities reporting febrile reactions were positive for elevated levels of endotoxin. To date, all the patients have recovered.
Although propofol is commonly used in veterinary medicine, a Teva spokeswoman said the company’s anesthetic agent is not approved for veterinary use and Teva does not market it to veterinarians.
Customers who have a tainted lot should stop using the product and return it to the distributor.
The FDA, the Centers for Disease Control and Prevention and Teva are continuing the investigation.
Teva is a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. of Israel.