14 batches of drugs do not comply with regulations. State Food and Drug Administration: Suspend sales and use, recall!

2023-08-21

The website of the National Food and Drug Administration announced today that 14 batches of drugs do not comply with regulations. The announcement is as follows: After inspection by 4 drug inspection institutions including Shanghai Institute for Food and Drug Inspection and Research, it was found that 14 batches of drugs produced by 11 enterprises do not meet the regulations. The relevant situation is hereby notified as follows: 1. After inspection by the Shanghai Food and Drug Inspection and Research Institute, it is indicated that the three batches of tacrolimus ointment produced by Shandong Ruian Pharmaceutical Co., Ltd. on behalf of Chifeng Wanze Pharmaceutical Co., Ltd. do not meet the requirements, and the items that do not meet the requirements are related to the quality of the substance. After inspection by the China Academy of Food and Drug Control, it was found that the first batch of Olotadine Hydrochloride Eye Drops produced by Zhejiang Jianfeng Pharmaceutical Co., Ltd. did not meet the requirements, and the item that did not meet the requirements was the packaging quantity. After inspection by the Shenzhen Institute for Drug Control and Research, it was found that the first batch of fried silkworms produced by Shanxi Kangyi Hengtai Pharmaceutical Co., Ltd. did not meet the requirements, and the items that did not meet the requirements were their properties and total ash content. After inspection by the Zhejiang Provincial Institute of Food and Drug Inspection and Research, it is marked as Hebei Runhua Pharmaceutical Co., Ltd., Hebei Kangyiqiang Pharmaceutical Co., Ltd., Anhui Xusong Traditional Chinese Medicine Slice Co., Ltd., Anhui Zehua Traditional Chinese Medicine Slice Co., Ltd., Shandong Qianhe Traditional Chinese Medicine Slice Co., Ltd., Chengdu Hexiangtian Pharmaceutical Co., Ltd., Yulin Guangjitang Traditional Chinese Medicine Development Co., Ltd The 9 batches of fried sour jujube kernels produced by Xinjiang Enze Traditional Chinese Medicine Slices Co., Ltd. do not meet the requirements, and the non compliant item is water content. 2、 For the above-mentioned drugs that do not comply with regulations, the drug regulatory department has requested relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc., investigate the reasons for the non-compliance, and effectively carry out rectification. 3、 The National Drug Administration requires relevant provincial-level drug regulatory departments to organize investigations into suspected illegal activities of the above-mentioned enterprises and units in accordance with the Drug Administration Law of the People's Republic of China, and publicly disclose the results of the investigation and punishment in accordance with regulations. (Reporter Yu Jingying)

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