1批维库溴铵因含有颗粒物而被召回

圣路易斯(MD Consult)——2012年6月28日，美国食品药品管理局(FDA)宣布，贝德福德实验室正在主动召回1个批次(批号2067134，保质期至2013年5月31日)20 mg瓶装维库溴铵注射剂。召回原因是在这一批次的少数药瓶中发现了颗粒物。这些颗粒物是在给药后检查中发现。到目前为止，尚未收到任何与被召回批次药物相关的不良事件报告。

颗粒物被认为对健康具有潜在危害。不良反应可能包括静脉刺激和静脉炎，常规尸检时发现临床隐匿性肺肉芽肿，局部组织梗死，严重肺功能障碍，毛细血管和动脉闭塞，过敏性休克，以及死亡。

维库溴铵适用于辅助全身麻醉以便于气管插管，并有助于在手术或机械通气过程中使骨骼肌松弛。

目前正在通知已购买了这批产品的消费者有关召回的信息。与使用应召回产品有关的不良反应，可报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On June 28, 2012, the US Food and Drug Administration (FDA) announced that Bedford Laboratories is conducting a voluntary recall of 1 lot (lot 2067134, expiration date 5/31/2013) of vecuronium bromide for injection in 20-mg vials. The reason for the recall is the discovery of particulate matter in a small number of vials within this specific lot. The discovery was made during a post-release inspection. To date, no reports of any adverse events for the lot being recalled have been received.

Particulate matter has been recognized as a potential health hazard. Adverse reactions may include vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, local tissue infarction, severe pulmonary dysfunction, occlusion of capillaries and arteries, anaphylactic shock, and death.

Vecuronium bromide is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Notification of this vecuronium bromide recall is being sent to customers who have received product from the identified lot. Adverse reactions experienced with the use of the recalled product may be reported to the FDA's MedWatch Adverse Event Reporting Program.