食品药品监管局刊登全国召回：Par Health阿加曲班注射液22个批次检出颗粒物 召回至用户级
美国食品药品监管局（FDA）10月14日刊登召回公告：制药商Par Health宣布在全国范围召回22个批次的阿加曲班注射液，召回层级至医院与用户级别。公司于10月13日先行宣布了这一召回。
召回原因是产品中检出颗粒物，成分包括纤维素、聚苯乙烯、聚对苯二甲酸乙二醇酯（PET）、瓶塞材料以至不锈钢颗粒。注射液中的异物颗粒可能带来血管堵塞等风险。截至公告时，公司尚未收到与本次召回相关的不良事件报告。
阿加曲班是一种抗凝药物，用于肝素诱导的血小板减少症患者的抗凝治疗。FDA提醒持有相关批次产品的医疗机构与患者按公告核对批号并停止使用，召回详情与批次清单见FDA官网召回页面。
FDA Posts Nationwide Recall of Par Health Argatroban Injection After Particles Found in 22 Lots
The U.S. Food and Drug Administration (FDA) on October 14 posted a nationwide recall of 22 lots of argatroban injection by Par Health, recalled down to the hospital and user level. The company had announced the recall on October 13.
The recall was issued after particulate matter was found in the product, including cellulose, polystyrene, polyethylene terephthalate (PET), vial-stopper material and even stainless steel particles. Foreign particles in an injectable drug can pose risks such as blood-vessel blockage. The company said it had received no adverse-event reports related to the recall as of the announcement.
Argatroban is an anticoagulant used to treat patients with heparin-induced thrombocytopenia. The FDA advises hospitals and patients holding the affected lots to check the lot numbers in the notice and stop using the product; the full lot list is on the FDA's recall page.
发布：GSM·美国（发布链接）
图片来源：图：医护人员演示静脉输液操作。摄影：美国海军，公共领域，来源：Wikimedia Commons / Photo: A corpsman demonstrates inserting an intravenous drip. Credit: U.S. Navy, public domain, via Wikimedia Commons
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