FDA确认新英格兰配药中心另外两个药物受细菌感染
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FDA确认新英格兰配药中心另外两个药物受细菌感染
笔记 2012-11-02 FDA 美国食品与药品监督管理局（FDA）及疾病控制与预防中心（CDC）11月1日宣布在NECC提供的另外两个召回产品-无防腐剂注射剂betamethasone及无防腐剂注射剂cardioplegia 中检出细菌，其中betamethasone三个独立批次均检出不同的结果，cardioplegia一个批次中检出有细菌。 详情请见原文链接。  The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are reporting laboratory results from samples of two additional recalled NECC products – preservative-free injectable betamethasone and cardioplegia solution. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA). The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free injectable betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution. |