The State Food and Drug Administration announced 49 batches of drugs that do not meet regulations
2023-07-19
After inspection by 10 drug inspection institutions including Gansu Provincial Institute for Drug Control and Research, 49 batches of drugs labeled as calcium carbonate D3 granules produced by 16 enterprises including Beijing Langdi Pharmaceutical Co., Ltd. do not meet the requirements. The relevant information is hereby announced as follows: 1. After inspection by the Tibet Autonomous Region Institute for Food and Drug Control, one batch of compound zinc cloth granules marked as produced by Hebei Jinniuyuan Pharmaceutical Science and Technology Co., Ltd. does not meet the requirements, and the item that does not meet the requirements is content determination. After inspection by Gansu Provincial Institute for Drug Control and Research, it was found that the 24 batches of calcium carbonate D3 particles produced by Beijing Zhendong Langdi Pharmaceutical Co., Ltd., Shanxi Zhendong Pharmaceutical Co., Ltd. entrusted by Beijing Zhendong Langdi Pharmaceutical Co., Ltd., and Shanxi Zhendong Kangyuan Pharmaceutical Co., Ltd. entrusted by Beijing Zhendong Kangyuan Pharmaceutical Co., Ltd. do not meet the requirements, and the items that do not meet the requirements are all content measurements. After inspection by Gansu Provincial Institute for Drug Control and Research, it was found that the 7 batches of calcium carbonate D3 particles (II) produced by Shanxi Zhendong Pharmaceutical Co., Ltd. entrusted by Beijing Langdi Pharmaceutical Co., Ltd. do not meet the requirements, and all items that do not meet the requirements are content determination. After inspection by Gansu Provincial Institute for Drug Control and Research, it was found that the batch of calcium carbonate D3 tablets (II) produced by Shanxi Zhendong Pharmaceutical Co., Ltd. entrusted by Beijing Langdi Pharmaceutical Co., Ltd. did not meet the requirements, and the item that did not meet the requirements was content determination. Upon inspection by Guangdong Provincial Institute for Drug Control, the batch of Diclofenac Sodium Enteric coated Tablets marked as produced by Changchun Xin'an Pharmaceutical Co., Ltd. did not meet the requirements, and the unqualified item was the amount dissolved in buffer solution. After inspection by Jiangsu Institute of Food and Drug Supervision and Inspection, one batch of levocarnitine oral solution marked as produced by Shandong Yikang Pharmaceutical Co., Ltd. does not meet the requirements, and the item that does not meet the requirements is Sodium benzoate. After inspection by the Liaoning Provincial Institute for Drug Inspection and Testing, it was found that the batch of trauma drop tablets produced by Anhui Yongshengtang Pharmaceutical Co., Ltd. did not meet the requirements, and the non compliant items were weight differences. After inspection by Shandong Provincial Institute for Food and Drug Inspection and Research, it was found that the two batches of musk analgesic cream produced by Hunan Jinshou Pharmaceutical Co., Ltd. did not meet the requirements, and the non compliant item was the adhesion test. After inspection by Chongqing Institute of Food and Drug Inspection and Testing, it was found that the three batches of Danshen formula granules produced by Yuzhou Tianyuan Pharmaceutical Co., Ltd. do not meet the requirements, and the non compliant item is content determination. According to the inspection of the Ningxia Institute for Drug Control, the three batches of ground skeletons produced by Luzhou Baicaotang Chinese Herbal Pieces Co., Ltd., Sichuan Ziqiang Chinese Herbal Medicine Co., Ltd. and Jiangxi Heshuo Pharmaceutical Co., Ltd. do not meet the requirements, and the items that do not meet the requirements include total ash content and water content. After inspection by Anhui Provincial Institute for Food and Drug Inspection and Research, it was found that the first batch of Fangself produced by Jiangxi Xinjian Pharmaceutical Co., Ltd. did not meet the requirements, and the non compliant item was water content. The four batches of privet fruit produced by Anguo Runde Pharmaceutical Co., Ltd., Hebei Runhua Pharmaceutical Co., Ltd., Jiuzhou Hengyuan (Anguo) Pharmaceutical Co., Ltd., and Sichuan Tongchuang Kangneng Pharmaceutical Co., Ltd., which are marked as unqualified by the inspection of China Foods Limited and Drug Control Institute, are water. 2、 For the above-mentioned drugs that do not comply with regulations, the drug regulatory department has requested relevant enterprises to
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