ST LOUIS (MD Consult) - On July 30, 2010, Lundbeck Inc announced that it is conducting a voluntary recall of 2 lots of NeoProfen (ibuprofen lysine), an injectable nonsteroidal antiinflammatory drug (NSAID) used in the treatment of premature infants with patent ductus arteriosus. The recall includes product lots 1734991 (expiration date, April 2011) and 1922319 (expiration date, March 2012).

The recall was prompted by an internal company inspection of the involved product lots that showed a failure to meet a visible-particulate quality requirement. Because these two lots are the only lots currently available to prescribers, this recall will result in a temporary drug shortage.

To date, the manufacturer has not received adverse event reports or product complaints attributable to visible particulates from any lot of NeoProfen, including the lots that are being recalled. Particulate matter has the potential to obstruct blood vessels, which could induce pulmonary emboli or activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with intravenous injection of particulate matter include foreign-body granulomas and local irritation of blood vessels. The potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal.

Any adverse events that may be related to the use of these products should be reported to the US Food and Drug Administration's MedWatch Program.

圣路易斯(MD Consult)——2010年7月30日，Lundbeck公司宣布主动召回两个批号的NeoProfen (布洛芬赖氨酸盐)，即一种用于治疗早产儿动脉导管未闭的注射用非甾体抗炎药(NSAID)。召回的产品批号包括1734991 (截止日期：2011年4月)和1922319 (截止日期： 2012年3月)。

此次召回是在一次公司内部检查发现上述两个批号的药品未达到可见微粒质量要求后做出的举措。由于这两个批号是目前处方者仅有的批号，故此次召回会引起暂时性药品短缺。

迄今，生产厂家尚未收到由任何批号NeoProfen中的可见微粒引起的不良事件报告或产品投诉，其中包括正被召回的批号。微粒物质可阻塞血管，继而引发肺栓塞，或激活血小板和(或)中性粒细胞引发过敏反应。静脉注射微粒物质还会引起异物肉芽肿和局部血管刺激征等其他不良反应。使用有微粒的无菌注射液可引起非常严重的不良事件，甚至有可能致死。

医生或患者请将可能与使用上述产品有关的任何不良事件上报至美国食品药品管理局(FDA)的MedWatch Program。