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两款注射液多个批次现不良反应 遭下令召回

2017-09-25 07:21:53   中国经济网

每经记者 谢欣 每经编辑 文多

9月23日晚间,食药监总局紧急通报:山西振东安特生物制药有限公司(下简称振东安特生物)生产的红花注射液、江西青峰药业有限公司(下简称青峰药业)生产的喜炎平注射液,两者的多个批次药品发生不良反应,要求所有医疗机构立即停止使用涉事批次产品,并责令企业召回问题批号产品。

振东安特生物为振东制药(300158,SZ)全资子公司,9月24日,振东安特生物方面对《每日经济新闻》记者表示“无法回应”,而青峰药业相关人士则对记者表示“将按照总局要求,召回涉事药品并做进一步核查”。

在多地发生不良反应

据食药监总局9月23日晚通告,今年8月底振东安特生物生产的红花注射液(批号:20170404)在山东、新疆等地发生10例寒战、发热等不良反应。9月22日,经山东省食品药品检验研究院检验,该批次药品热原不符合规定。

此外,近日青峰药业生产的喜炎平注射液在甘肃(涉事批号:2017041303)、黑龙江(涉事批号:2017042303)、江苏(涉事批号:2017061003)共发生十多例寒战、发热等严重不良反应。事发地食品药品监管部门目前还正在对涉事产品进行检验。

食药监总局表示,振东安特生物制药生产的涉事批次红花注射液共销往山西、江苏、安徽、福建、山东、河南、湖南、贵州、陕西、新疆等10省(区)。青峰药业生产的涉事批次喜炎平注射液共销往北京、天津、河北、山西、内蒙古、辽宁等28省(区、市)。

食药监总局同时要求所有医疗机构立即停止使用上述批号产品,并责令两家涉事药企立即召回上述批号产品。要求山西、江西省食品药品监督管理局监督企业停止涉事品种的销售,确保药品全部召回。药品流入地的省(区、市)食品药品监督管理部门密切关注药品流通使用情况,并监督相关企业和医疗机构配合召回上述药品。

食药监总局还责令两家企业停止上述产品销售,并彻查药品质量问题原因,针对查明的原因进行整改。在未查明原因、未整改到位之前不得恢复销售。山西、江西省食品药品监督管理局负责监督上述措施的落实,并对相关药品生产企业立案调查,依法严肃查处违法违规行为。

通报发出后,青峰药业方面向《每日经济新闻》记者表示,总局在发函前并非事先告知公司,公司方面也是今天上午刚刚得知此事,恰好9月24日是休息日,公司目前正在与分销商等紧急开会应对,“具体是哪些批次总局都写的很清楚了,我们会按照食药监总局要求进行召回检验”。

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