Two lots of the anesthetic propofol are being recalled by Teva Pharmaceuticals after testing showed the lots had elevated levels of endotoxin, according to the U.S. Centers for Disease Control and Prevention (CDC).
Teva “is initiating a voluntary recall for these lots, and clinicians are advised to immediately stop using these lots of Teva Pharmaceuticals propofol,” the CDC said in a health advisory issued Monday evening. The lot numbers are 31305429B and 31305430B, according to the CDC.
The action came following an investigation of recent cases of febrile reactions among human patients undergoing endoscopy in the United States, the CDC said. The investigation showed that all of the patients had received propofol from 100 ml vials manufactured by Teva Pharmaceuticals, and tests showed that two lots of the product that were in use in the facilities “were positive for elevated levels of endotoxin,” the CDC said.
For more information, view the FDA press release.
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