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According to Japanese media reports, Kobayashi Chemical, a Japanese pharmaceutical company, was ordered to suspend production for rectification 1 16 days. It is reported that its oral medicine for treating tinea pedis and other diseases contains excessive hypnotic ingredients, which has damaged the health of more than 200 people. From June 5438 to February 2020, after the above violations were exposed, the authorities found that the company had been faking for 40 years. About 80% of 500 kinds of drugs have forged records. At present, the president and other managers have been acquiescing in this behavior.

Itraconazole tablets produced by Kobayashi Chemical Company for the treatment of tinea pedis and other diseases are mixed with hypnotic ingredients, and the maximum limit is 2.5 times that stipulated by Japan, which harms the health of 239 patients taking this prescription drug. Some patients lost consciousness after taking this medicine, and 22 traffic accidents happened. Two others died after taking the medicine, but it is not known whether there is a causal relationship between the death of these two people and taking the medicine.

According to reports, the consequences of the above-mentioned illegal operations were exposed in February 65438+2020. On February 9th, Fukui government ordered the company to suspend business for rectification 1 16 days, which was the longest time for Japanese pharmaceutical companies to suspend business for rectification due to violation of the Law on Medicines and Medical Devices.

After the above problems came out, Kobayashi Pharmaceutical also issued a statement at the first time to explain the specific situation to domestic users. Kobayashi Pharmaceutical said in the statement that Kobayashi Chemical Co., Ltd. and its parent company Kobayashi Pharmaceutical Co., Ltd. do not have any investment relationship or related relationship, and there is no specific relationship such as authorized operation and brand promotion. According to the company's regulations, it takes two people to point out and confirm when weighing raw materials, but only one person in charge was working at that time.

All affiliated enterprises of Kobayashi Pharmaceutical in China are Kobayashi Pharmaceutical (China) Co., Ltd., Shanghai Kobayashi Daily Chemical Co., Ltd., Hefei Kobayashi Pharmaceutical Co., Ltd. and Jiangsu Kobayashi Pharmaceutical Co., Ltd., and these five companies are not affiliated with Kobayashi Chemical.

Kobayashi Chemical said in the recall notice that we are currently studying all products. As one of the investigations, we investigated the previous inspection records, and the results of the on-site inspection reports conducted by the Executive Board on 2 1 and 22/of this month found that many of the following products needed to be reconfirmed. It has been confirmed that because the products stored by our company have been rechecked, no problems have been found in any products. We think there is no serious health risk, but it can improve safety.