全国停售!召回!
<p style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);visibility: visible;"><br/></p><pre style="margin: 5px auto 16px;outline: 0px;letter-spacing: 0.544px;text-decoration: inherit;white-space: normal;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;background-color: rgb(255, 255, 255);line-height: 1.75em;visibility: visible;font-size: 16px;border-width: initial;border-style: none;border-color: rgb(216, 40, 33);-webkit-tap-highlight-color: transparent;overflow: auto;color: rgb(51, 51, 51);word-break: break-all;"><section style="margin: 5px 16px 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;text-decoration: inherit;border-width: initial;border-style: none;border-color: rgb(216, 40, 33);-webkit-tap-highlight-color: transparent;overflow: auto;word-break: break-all;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">国家药监局发布:49批次药品不符合规定的通告,其中</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;text-decoration: inherit;">朗迪钙质量抽检不合格独占<span style="outline: 0px;">30多批</span><span style="outline: 0px;">次</span>......</span></section><section style="margin: 5px 16px 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;text-decoration: inherit;border-width: initial;border-style: none;border-color: rgb(216, 40, 33);-webkit-tap-highlight-color: transparent;overflow: auto;word-break: break-all;text-align: center;"><strong style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;color: rgb(2, 30, 170);visibility: visible;">这49批次药品停售召回,赶紧自查!</span></strong></section><section style="margin: 5px 16px 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;text-decoration: inherit;border-width: initial;border-style: none;border-color: rgb(216, 40, 33);-webkit-tap-highlight-color: transparent;overflow: auto;word-break: break-all;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">7月17日,国家药监局发布《</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">关于49批次药品不符合规定的通告》(2023年第30号)。</span></section><section style="margin: 5px 16px 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;text-decoration: inherit;border-width: initial;border-style: none;border-color: rgb(216, 40, 33);-webkit-tap-highlight-color: transparent;overflow: auto;word-break: break-all;"></section><pre style="margin: 5px auto 16px;outline: 0px;white-space: normal;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;text-decoration: inherit;border-width: initial;border-style: none;border-color: rgb(216, 40, 33);-webkit-tap-highlight-color: transparent;overflow: auto;word-break: break-all;">通告内容如下:经甘肃省药品检验研究院等10家药品检验机构检验,标示为北京朗迪制药有限公司等16家企业生产的碳酸钙D3颗粒等49批次药品不符合规定。</pre><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;"><strong style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;color: rgb(2, 30, 170);visibility: visible;">不合格检测品种:</span></strong><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;"><br style="outline: 0px;visibility: visible;"/></span></section><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;"><strong style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;color: rgb(2, 30, 170);visibility: visible;">化药:</span></strong><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">复方锌布颗粒剂(1批次)、</span><span style="outline: 0px;color: rgb(217, 33, 66);font-size: 15px;letter-spacing: 1px;visibility: visible;">碳酸钙D3颗粒(24批次)、碳酸钙D3颗粒(Ⅱ)(8批次)、</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">双氯芬酸钠肠溶片(1批次)、左卡尼汀口服溶液(1批次);</span></section><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;"><strong style="outline: 0px;letter-spacing: 0.578px;visibility: visible;"><span style="outline: 0px;letter-spacing: 1px;visibility: visible;"><span style="outline: 0px;color: rgb(2, 30, 170);visibility: visible;">中药:</span></span></strong><span style="outline: 0px;visibility: visible;">伤科跌打片(1批次)、</span><span style="outline: 0px;visibility: visible;">麝香镇痛膏(2批次)、</span><span style="outline: 0px;visibility: visible;">丹参配方颗粒(3批次)、</span><span style="outline: 0px;visibility: visible;">地骨皮(3批次)、</span><span style="outline: 0px;visibility: visible;">防己(1批次)、</span><span style="outline: 0px;visibility: visible;">女贞子(4批次)。</span></span></section><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">令人唏嘘的是,其中,号称“适合中国人体质”的朗迪牌碳酸钙D3颗粒,即“朗迪钙”就独占30多批次。</span></section><pre style="margin: 5px auto 16px;outline: 0px;text-decoration: inherit;white-space: normal;font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;border-width: initial;border-style: none;border-color: rgb(216, 40, 33);-webkit-tap-highlight-color: transparent;overflow: auto;word-break: break-all;">“经甘肃省药品检验研究院检验,标示为北京振东朗迪制药有限公司、北京振东朗迪制药有限公司委托山西振东制药股份有限公司、北京振东康远制药有限公司委托山西振东制药股份有限公司生产的24批次碳酸钙D3颗粒不符合规定,不符合规定项目均为含量测定。经甘肃省药品检验研究院检验,标示为北京朗迪制药有限公司委托山西振东制药股份有限公司生产的7批次碳酸钙D3颗粒(Ⅱ)不符合规定,不符合规定项目均为含量测定。经甘肃省药品检验研究院检验,标示为北京朗迪制药有限公司委托山西振东制药股份有限公司生产的1批次碳酸钙D3片(Ⅱ)不符合规定,不符合规定项目为含量测定。”</pre><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;"><span style="outline: 0px;color: rgb(217, 33, 66);"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">上述被判定为不合格的“朗迪钙”的批号有</span><span style="outline: 0px;visibility: visible;font-size: 15px;letter-spacing: 1px;">:</span></span><span style="outline: 0px;letter-spacing: 1px;visibility: visible;font-size: 14px;color: rgb(136, 136, 136);">20220506、20220515、20220602、W20211118、W20220103、W20220117、W20220204、W20220307、W20220408、W20220611、W20220620、W20220621、W202110145、W20220157、W20220241、W20220479、W20220432、W20220464、W20220580、W202205145、W20220654、W20220664、W20220666、W20210203、W20220815、W20220816、W202207183、W202210150、W20220907、W20221075、W202210123、W20220932。</span></section><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;"><strong style="outline: 0px;letter-spacing: 0.578px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;color: rgb(2, 30, 170);visibility: visible;">49批次药品不合格检测项目:</span></strong></section><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;visibility: visible;"><strong style="outline: 0px;letter-spacing: 0.578px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;color: rgb(2, 30, 170);visibility: visible;"></span></strong><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">含量、</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">缓冲液中溶出量、</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">苯甲酸钠、</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">重量差异、</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">黏附力测定、</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">总灰分、水分。</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;"></span></section><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.578px;line-height: 1.75em;visibility: visible;"><strong style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;color: rgb(2, 30, 170);visibility: visible;">纠偏措施:</span></strong><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">对上述不符合规定药品,药品监督管理部门已要求相关企业和单位采取暂停销售</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;color: rgb(217, 33, 66);">使用、召回</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">等风险控制措施,对不符合规定原因开展调查并切实进行整改。</span></section><section style="margin-right: 16px;margin-bottom: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.578px;line-height: 1.75em;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;">同时,国家药监局要求相关省级药品监督管理部门依据《中华人民共和国药品管理法》,</span><span style="outline: 0px;font-size: 15px;letter-spacing: 1px;visibility: visible;color: rgb(217, 33, 66);">组织对上述企业和单位存在的涉嫌违法行为立案调查,并按规定公开查处结果。</span></section><section style="margin-right: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;text-align: center;"><span style="outline: 0px;font-size: 18px;"><strong style="outline: 0px;"><span style="outline: 0px;color: rgb(72, 72, 72);caret-color: rgb(0, 116, 149);">49批次不符合规定药品名单</span></strong></span></section><section style="margin-right: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;text-align: center;"><br style="outline: 0px;"/></section><section style="margin-right: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;text-align: center;"></section><section style="margin-right: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;text-align: center;"></section><section style="margin-right: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;text-align: center;"></section><section style="margin-right: 16px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;line-height: 1.75em;text-align: center;"></section></pre><p><br/></p><section style="margin-right: 16px;margin-bottom: 0px;margin-left: 16px;outline: 0px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);color: rgb(160, 160, 160);font-family: -apple-system-font, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;font-size: 14px;line-height: 1.75em;visibility: visible;"><span style="outline: 0px;letter-spacing: 2px;font-size: 12px;">来源:国家药监局</span></section><p><br/></p><p style="display: none;"><mp-style-type data-value="3"></mp-style-type></p><p><br/></p><link rel="stylesheet" href="//www.singse.com/source/plugin/wcn_editor/public/wcn_editor_fit.css?v134_nis" id="wcn_editor_css"/>
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