迈兰制药因产品缺陷发布召回

一片红云

近日，FDA官网挂出警告消费者关注迈兰制药召回其EpiPens肾上腺素笔。

EpiPen是迈兰制药推出的肾上腺素笔，是目前市场上使用最为广泛的预充式肾上腺素注射装置，专用于严重致命性过敏反应的院外急救治疗，也被称为救命药。

目前，迈兰对该产品的召回范围还包括：澳大利亚，新西兰，日本和欧洲等。

该公司在一份声明中称，此次召回事件是由于发生了两起设备故障，原因是供应商组件有潜在缺陷。

以下是FDA官网对该召回信息的摘译：

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate.
美国FDA提醒消费者关注Meridian医疗技术有限公司主动召回13批迈兰用于紧急治疗严重过敏反应的EpiPen和EpiPen Jr（肾上腺素注射剂）自动注射器产品。该召回是由于这些产品可能有缺陷部件，可能导致产品难以激活。

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall.
此时，已确定在2015年12月17日到2016年7月1日期间销售的13批受美国召回影响。

Product/Dosage
NDC Number
Lot Number
Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg
49502-501-02
5GN767
April 2017
EpiPen Jr Auto-Injector, 0.15 mg
49502-501-02
5GN773
April 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
5GM631
April 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
5GM640
May 2017
EpiPen Jr Auto-Injector, 0.15 mg
49502-501-02
6GN215
September 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
6GM082
September 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
6GM072
September 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
6GM081
September 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
6GM088
October 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
6GM199
October 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
6GM091
October 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02
6GM198
October 2017
EpiPen Auto-Injector, 0.3 mg
49502-500-02

scslk0045

这个损失很惨重啊

yuh0693

学习了 谢谢楼主

小金库

谢谢分享