ST LOUIS (MD Consult) - On July 17, the US Food and Drug Adminstration announced that Teva Pharmaceuticals is initiating a voluntary recall of propofol injectable emulsion in 10-mg/ml 100-ml vials, lot numbers 31305429B and 31305430B. These product lots are being recalled because the presence of elevated endotoxin levels was noted in some vials within these lot numbers.

Teva has been notified of 41 propofol-treated patients who experienced postoperative fever, chills, and other flu-like symptoms. Adverse health effects, such as fever, chills, or rigors, are possible with exposure to products with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to products with high endotoxin levels.

Customers who have propofol lots 31305429B or 31305430B in their possession are instructed to cease using the product and return it to their distributor. Consumers with questions may contact 1-866-262-1243 from 8:00 AM to 8:00 PM Eastern Daylight Time, Monday through Friday.

Propofol is intended to be administered by appropriately trained professionals in the settings of the operating room and the intensive care unit. The drug is considered an anesthetic and a sedative agent.

圣路易斯(MD Consult)——7月17日，美国食品药品管理局(FDA)宣布，梯瓦制药公司将开始主动召回10 mg/ml、100ml玻璃瓶装、批号为31305429B和31305430B的 异丙酚注射用乳剂。这些产品批次被召回的原因为，某些瓶中的内毒素水平偏高。

梯瓦公司已接到通知，有41例接受异丙酚治疗的患者术后出现高热、寒战以及其他感冒样症状。应用内毒素水平偏高的药品可能引发高热、寒战等不良健康效应，而应用内毒素水平高的药品后则会出现严重的不良反应，诸如弥散性血管内凝血、急性呼吸窘迫综合征、休克甚至死亡。

对于存有批号为31305429B 或 31305430B异丙酚的患者，应通知其停药，并将药品退给其分销商。患者如有疑议，可于周一至周五美国东部夏令时间早8:00至晚8:00致电1-866-262-1243咨询。

异丙酚应由经过正规培训的专业人员在手术室或重症监护病房使用，是一种麻醉性镇静药。