Medical network - on April 14, April 13, the CFDA website "about 6 batches pharmaceutical excipients unqualified notice no. 55 (2017)", said by the food and drug verification research institute of China, such as three drug inspection agency inspection, hongfa double labeled tianjin sheng vaseline co., LTD. Three companies such as the production of pharmaceutical excipients unqualified 6 batches.
Rejected product labeling, commodity production enterprises and production batch number is: tianjin city hongfa double sheng vaseline Co., Ltd., production batch number is 20160421-1, 20160422-1, 20160718-1, 20160719-1 white petroleum jelly, Anhui Sunhere Pharmaceutical Excipients Co., ltd. production of the batch number is 150604 times he cyclodextrin, hunan China, Pharmaceutical Co., Ltd., production batch number is 20160501 of polyethylene glycol (peg) 400. Clarity and color of the unqualified project has a solution, absorbance of impurities, polycyclic aromatic hydrocarbons, triethylene glycol.
For the unqualified products, the relevant provinces, autonomous regions and municipalities directly under the food and drug administration has taken seized seized control measures, such as requiring companies to suspend sales use, recalls, and rectification.
CFDA request production enterprises home provinces (autonomous regions and municipalities) food and drug administration of the enterprise on the basis of the "drugadministration law of the People's Republic of China" and other regulations, illegal activities of production and sales of unqualified products to initiate an investigation, public three months for production and sales of unqualified products processing result of relevant enterprises or units, administration of relevant situation report in time.
6 batches unqualified medicinal materials list
品名
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标示生产企业
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生产批号
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检品来源
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检验依据
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检验
结果
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不合格项目
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检验机构
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白凡士林
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天津市宏发双盛凡士林有限公司
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20160421-1
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国药集团三益药业(芜湖)有限公司
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《中华人民共和国药典》2015年版四部
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不合格
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[检查]（多环芳香烃）
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湖南省药品检验研究院
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20160422-1
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福元药业股份有限公司
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20160718-1
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天津市宏发双盛凡士林有限公司
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20160719-1
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倍他环糊精
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安徽山河药用辅料股份有限公司
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150604
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安庆乘风制药有限公司
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《中华人民共和国药典》2010年版二部
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不合格
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[检查]（溶液的澄清度与颜色）、（杂质吸光度）
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广东省药品检验所
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聚乙二醇400
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湖南华日制药有限公司
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20160501
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湖南华日制药有限公司
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《中华人民共和国药典》2015年版四部
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不合格
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[检查]（三甘醇）
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中国食品药品检定研究院
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