一批默克乙肝疫苗因药瓶可能破裂而被召回

圣路易斯(MD Consult)——2013年7月3日，美国食品药品管理局(FDA)宣布，默克已开始主动召回1个批次(批号J001183)的Recombivax HB，后者是一种用于预防乙型肝炎的疫苗。默克调查发现，该批产品中的某些药瓶可能有裂痕。假如药瓶破裂，就无法确保其内容物的无菌性。

该批产品均应被隔离。已经注射了应召回产品的患者不需要再次接种。

应将与使用这批产品有关的不良事件或质量问题报告至FDA的疫苗不良事件报告系统。

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ST LOUIS (MD Consult) - On July 3, 2013, the US Food and Drug Administration (FDA) announced that Merck has initiated a voluntary recall of 1 lot (lot# J001183) of Recombivax HB, a vaccine indicated as prophylaxis against hepatitis B. Merck's investigation concluded that for certain vials in the affected lot, the potential exists for cracks in the vials. If a vial was cracked, the integrity of the vial and the sterility of any product remaining in the vial could not be assured.

All product from this lot should be quarantined. If a product from this lot has been administered, revaccination is not necessary.

Adverse events or quality problems related to use of this product should be reported to the FDA's Vaccine Adverse Event Reporting System.