2批眼科产品Mitosol因可能存在酵母菌污染而被召回

圣路易斯(MD Consult)——2013年1月10日，美国食品药品管理局(FDA)宣布，Mobius Therapeutics正在主动召回2个批次(M098260和M086920)的Mitosol(丝裂霉素溶液)，规格为0.2 mg/瓶，用于眼科适应证。该公司担心，这2个批次的药物可能并非无菌而是含有某种酵母菌。Mobius已开始进行调查，以确定原因、纠正错误和采取预防措施。

Mitosol适用于辅助巩膜切开青光眼手术。假如使用可能受到污染的产品，可导致严重的眼部问题/感染，甚至可能致盲。Mobius尚未收到任何与本次召回有关的不良事件的报告。

这2批应召回产品已于2012年10月22日~12月14日期间被销往阿拉巴马、阿肯色、特拉华、佐治亚、伊利诺伊、印第安纳、马萨诸塞、缅因、密歇根、明尼苏达、密苏里、北卡罗来纳、新泽西、纽约、俄亥俄、宾夕法尼亚、田纳西、弗吉尼亚和威斯康辛等州。

建议将与使用这些产品有关的不良反应或质量问题报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On January 10, 2013, the US Food and Drug Administration (FDA) announced that Mobius Therapeutics is conducting a voluntary recall of 2 lots (M098260 and M086920) of Mitosol (mitomycin for solution) in 0.2 mg/vials contained in kits for ophthalmic use. The company is concerned that the affected lots may not be sterile and may contain a strain of yeast. Mobius has initiated an investigation to determine the root cause and corrective and preventative actions.

Use of these potentially contaminated products could result in serious eye problems/infections, including possible blindness. Mobius has not received any report of adverse events related to this recall.

These lots were distributed between 10/22/2012 and 12/14/2012 in Alabama, Arkansas, Delaware, Georgia, Illinois, Indiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin. Mitosol is indicated as an adjunct to ab externo ocular surgery for glaucoma.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting Program.