ST LOUIS (MD Consult) - On November 6, 2009, the US Food and Drug Administration and Hospira announced a recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, as well as 73 lots of propofol injectable emulsion 1% products whose lot numbers start with 79 or 80. The products are being recalled because some of the containers may contain particulate matter.
The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. Because the particulate contaminants do not dissolve in blood, they could potentially act as emboli and impede blood flow. Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, myocardial infarction, and/or death. Particulates may also cause mechanical damage to the body and may serve to escalate damage through the systemic inflammatory response syndrome.
Hospira has not received any reports of adverse events related to this issue. The company has also identified the root cause, and corrective actions have been implemented.
Liposyn is an intravenous fat emulsion used in total parenteral nutrition (TPN) therapy. Propofol is a sedative-hypnotic agent used in the induction and maintenance of sedation or anesthesia.
Any existing inventory of the products should be quarantined immediately, and a call should be placed to Stericycle at 1-866-654-0725 to arrange for product return. Medical inquiries should be directed to Hospira Medical Communications at 1-800-615-0187.
圣路易斯(MD Consult)——2009年11月6日,美国食品药品管理局(FDA)和Hospira共同宣布,召回85个批次的Liposyn II 10%,Liposyn II 20%,Liposyn III 10%,Liposyn III 20%和Liposyn III 30%,以及编号以79或80开头的73个批次的1%丙泊酚注射乳剂。此次召回是因为一些容器可能沾染了微粒物质。
微粒的来源是生产过程中的不锈钢设备。因为这些微粒不溶于血液,所以可能引起栓塞、阻断血流。组织血液供应不足将导致卒中、呼吸衰竭、肾功能衰竭、肝功能衰竭、心肌梗死,甚至死亡。微粒也可以造成机体的机械损害,并可引起全身炎性反应综合征(SIRS)而加重机体损伤。
Hospira尚未收到过任何关于此类副作用的报告。该公司已找到其根本原因,并已采取改进措施。
Liposyn是静脉应用的全肠外营养(TPN)脂肪乳剂。丙泊酚是镇静催眠药物,用于诱导和维持镇静或麻醉。
所有这些产品的库存应立即封存,可以致电1-866-654-0725给Stericycle公司咨询退货事宜。有关医疗问题可致电1-800-615-0187给Hospira公司。