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康美药业回应抽检不合格:因标准不同 已暂停销售

2018-06-24 14:55:00 北京商报 分享
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  康美药业 称抽检不合格因标准不同

  北京商报讯(记者 孙麒翔 郭秀娟)4月22日,康美药业发布《关于国家食品药品监督管理总局发布的关于33批次中药饮片不合格的通告的情况公告》称,国家食药监总局此前通报的康美药业不合格中药饮片产品各项指标均符合《浙江省中药炮制规范》标准检验要求,造成抽检不合格主要原因为检验标准依据不同。目前,康美药业已经暂停销售使用涉及批号产品,并按照《药品召回管理办法》启动召回程序和召回工作。

  4月20日,国家食药监总局发布关于33批次中药饮片不合格通告,其中康美药业160250191、160350281、160451101、160550271四批次菊花因(性状)项目不符合《中华人民共和国药典》2015年版一部相关要求。

  4月22日,康美药业针对上述批次产品不合格一事解释称,菊花品类中的胎菊没有相应的国家中药炮制标准。依据《中华人民共和国药品管理法》第十条规定,在没有国家标准规定的情况下,中药饮片必须按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制,而上述不合格产品各项指标均符合《浙江省中药炮制规范》标准检验要求。

  康美药业表示,此次抽检结果依据标准为《中国药典》中菊花性状指标为盛开时采摘花朵的菊花,康美药业的菊花检验标准为胎菊,花蕾期采摘的菊花,实为同一植物。康美药业表示,截至2018-06-24,涉及上述不合格批次产品销售金额为7.98万元,占该公司2016年营业收入的0.0004%。

责编:李芬
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