Initiate investigation, suspend sales and use! Recall! Officially named and exposed, 14 batches of drugs do not meet the required units | comply with regulations | officially

Release time:Apr 15, 2024 00:52 AM

The website of the National Medical Products Administration issued a notice today regarding 14 batches of drugs that do not comply with regulations.

The announcement is as follows:

After inspection by four drug inspection institutions including Shanghai Food and Drug Inspection and Research Institute, it was found that 14 batches of drugs produced by 11 enterprises did not meet the regulations. The relevant situation is hereby announced as follows:


1、 After inspection by the Shanghai Food and Drug Inspection and Research Institute, it was found 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 non compliant items are related substances.



According to the inspection conducted by the China Academy of Food and Drug Control, the first batch of Olotadine Hydrochloride Eye Drops produced by Zhejiang Jianfeng Pharmaceutical Co., Ltd. does not meet the requirements, and the item that does not meet the requirements is the dosage.

After inspection by Shenzhen Institute of Drug Control and Research, it was found that the first batch of fried stiff 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 appearance and total ash content.

After inspection by the Zhejiang Provincial Institute of Food and Drug Inspection and Research, it was found that 9 batches of roasted sour jujube kernels produced by Hebei Runhua Pharmaceutical Co., Ltd., Hebei Kangyiqiang Pharmaceutical Co., Ltd., Anhui Xusong Traditional Chinese Medicine Decoction Co., Ltd., Anhui Zehua Traditional Chinese Medicine Decoction Co., Ltd., Shandong Qianhe Traditional Chinese Medicine Decoction Co., Ltd., Chengdu Hexiangtian Pharmaceutical Co., Ltd., Yulin Guangjitang Traditional Chinese Medicine Development Co., Ltd., and Xinjiang Enze Traditional Chinese Medicine Decoction 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 suspending sales and use, recalling, etc., investigate the reasons for non-compliance, and effectively carry out rectification.




3、 The National Medical Products Administration requires relevant provincial 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 investigations in accordance with regulations.



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