State Food and Drug Administration: 36 batches of drugs are unqualified, and 20 batches of Nanjing Baijingyu Pharmaceutical Co., Ltd!

Recently, the State Food and Drug Administration issued the notice on 36 batches of drugs not conforming to the regulations, which was inspected by Jiangxi Institute of drug inspection and testing, indicating that 20 batches of chlortetracycline eye ointment produced by Nanjing Baijingyu Pharmaceutical Co., Ltd did not conform to the regulations According to the inspection of CFDA, the two batches of Chonglou produced by Hebei Qixin traditional Chinese medicine granule Yinpian Co., Ltd and Hebei Shuangning Pharmaceutical Co., Ltd did not meet the requirements According to the inspection of Henan food and Drug Inspection Institute, the 6 batches of Rehmannia glutinosa produced by Anguo Ping'an Pharmaceutical Co., Ltd., Bozhou Gaoguang Herbal Pieces Factory, Yibin Renhe Herbal Pieces Co., Ltd., Sichuan Shengshi Jinrong Pharmaceutical Co., Ltd., Lanzhou Xukang Pharmaceutical Co., Ltd and Xinjiang qikang Habo Herbal Pieces Co., Ltd do not meet the requirements According to the inspection of Henan food and Drug Inspection Institute, 4 batches of yams marked as produced by 4 enterprises, including Hebei jixintang Pharmaceutical Co., Ltd and Yunnan Jinfa Pharmaceutical Co., Ltd., do not meet the requirements In this notice, Nanjing Baijingyu Pharmaceutical Co., Ltd has 20 batches of chlortetracycline eye ointment, which is worth noting At present, there are 17 enterprises that hold production approval documents for domestic chlortetracycline eye ointment according to the database of domestic drugs of pharmaceutical intelligence Among them, 2g (0.5%) * 1 chlortetracycline eye ointment is Chenxin Pharmaceutical Co., Ltd and Nanjing Baijingyu Pharmaceutical Co It can be seen that Nanjing Baijingyu pharmaceutical has a large market share The following is the original announcement: 36 batches of drugs produced by 16 enterprises such as Nanjing Baijingyu Pharmaceutical Co., Ltd did not meet the requirements after inspection by 4 drug inspection institutions such as Jiangxi Institute of drug inspection and testing The relevant information is hereby announced as follows: 1 20 batches of Chlortetracy-cline Hydrochloride Eye Ointment marked as Nanjing Bai Jingyu Pharmaceutical Co., Ltd do not conform to the regulations after the inspection of Jiangxi Institute of drug inspection and testing, and the items that do not conform to the regulations are the granularity According to the inspection of CFDA, the two batches of Chonglou marked as produced by Hebei Qixin traditional Chinese medicine granule Yinpian Co., Ltd and Hebei Shuangning Pharmaceutical Co., Ltd do not meet the requirements, including thin-layer chromatography and content determination According to the inspection of Henan food and Drug Inspection Institute, the 6 batches of Rehmannia glutinosa produced by Anguo Ping'an Pharmaceutical Co., Ltd., Bozhou Gaoguang Chinese Herbal Pieces Factory, Yibin Renhe Chinese Herbal Pieces Co., Ltd., Sichuan Shengshi Jinrong Pharmaceutical Co., Ltd., Lanzhou Xukang Pharmaceutical Co., Ltd and Xinjiang qikang Habo Chinese Herbal Pieces Co., Ltd do not meet the requirements, including Determination of total ash, acid insoluble ash and content According to the inspection of Henan food and Drug Inspection Institute, the four batches of yams produced by four enterprises, such as Hebei jixintang Pharmaceutical Co., Ltd and Yunnan Jinfa Pharmaceutical Co., Ltd., do not meet the requirements, and the items that do not meet the requirements are the total ash content According to the inspection of Shanxi food and Drug Inspection Institute, the four batches of notopterygium Notopterygii produced by Chongqing yuhetang Pharmaceutical Co., Ltd., Chengdu Xinfuyuan Herbal Pieces Co., Ltd and Sichuan yuanshangcao Herbal Pieces Co., Ltd do not meet the requirements, and the items that do not meet the requirements include the determination of properties and contents (see the appendix for details) II For the above-mentioned non-conforming drugs, the relevant drug supervision and administration departments have required the relevant enterprises to suspend the sale and use of the products, recall the products, carry out the investigation on the causes of non-conforming drugs, and earnestly carry out in-depth rectification 3、 The State Drug Administration requires the relevant provincial drug supervision and administration departments to file and investigate the illegal activities of the above-mentioned enterprises and units in accordance with the provisions of Article 73, 74 and 75 of the drug administration law of the people's Republic of China, and complete the investigation and handling of the relevant enterprises or units within three months from the date of receiving the inspection report Disclose the results of processing Notice is hereby given Appendix: 1.36 list of batches of non-conforming drugs 2 Small knowledge of non-conforming items Appendix 2 of State Food and Drug Administration on March 21, 2019 small knowledge of non-conforming items 1 The properties of Chinese herbal pieces do not meet the requirements, which may involve the following situations: deviation of medicinal materials, defective processing technology, improper storage, etc 2、 Identification items are mainly used to distinguish drug characteristics, including microscopic identification, spectral identification, etc TLC is a common identification method 3、 Suspension type paste eye semi-solid preparation contains particles In order to avoid foreign body feeling in eyes, the particle size is tested 4、 The purpose of total ash determination is to detect the purity of traditional Chinese medicine 5、 Acid insoluble ash index is mainly used to detect the content of soil, sandstone and other impurities in traditional Chinese medicine Issued by the comprehensive planning and Finance Department of the State Drug Administration on March 22, 2019