Due to the problem that the ingredients of the sleep-inducing agent were mixed in the therapeutic drug such as athlete's foot manufactured by the drug manufacturer in Fukui prefecture, the manufacturer voluntarily collects another 20 kinds of drugs because the approved procedure was not followed. I learned from interviews with the people concerned that I decided on the policy.
The manufacturer has explained to the Ministry of Health, Labor and Welfare that "there is no possibility of serious health damage."
On the 23rd, there was an accident caused by losing consciousness while driving after taking the drug due to the problem that the component of the sleep-inducing agent was mixed in the therapeutic drug for athlete's foot and other mycoses manufactured and sold by Kobayashi Kako. 22 cases have been reported so far.
Kobayashi Kako is proceeding with the voluntary collection of the drug in question, but interviews with related parties revealed that it has decided to voluntarily collect another 20 types of drugs such as drugs for the treatment of hypertension and diabetes. It was.
Of these, the ointment used for local anesthesia was shipped after being retested without verification, even though bacteria were detected in the sterility test.
Even with the remaining drugs, the procedures approved by the government were not followed, such as shipping as a "temporary error" even though the test showed abnormal values.
The Ministry of Health, Labor and Welfare and others conducted an on-site investigation for two days until the 22nd, but at this time, Kobayashi Kako said, "There is no problem in the final test and there is no possibility of serious health damage." I explained that.
Kobayashi Kako has already stopped shipping all products, and the Ministry of Health, Labor and Welfare and others are continuing to investigate the status of detailed manufacturing control.