Nichi-Iko, a major generic drug company, repeatedly recalled a total of 75 products from April last year to January this year, and Toyama Prefecture suspended operations in March due to problems with the company's manufacturing and quality control systems. We have decided to issue an order.
According to the people concerned, Nichi-Iko conducted an in-house investigation after being pointed out by PMDA (Pharmaceuticals and Medical Devices Agency), which examines pharmaceutical products, that there was a problem with manufacturing and quality control at the Toyama Daiichi Plant in Namerikawa City.
As a result, some products that are "non-conforming" in the shipping test are retested by an inappropriate method, and some products are shipped as "conforming" or manufactured in a process different from the process approved by the country. Was found and we proceeded with voluntary recall.
From April to January of last year, Nichi-Iko has voluntarily recalled a total of 75 products, including anti-allergic drugs such as pollinosis, gastrointestinal drugs, and drugs that suppress blood sugar levels to improve diabetes.
According to Toyama Prefecture, no health hazards have been confirmed so far, but the prefecture does not comply with the manufacturing and quality control procedures and methods based on the law, and the prefecture voluntarily recalls 75 items of products. As the reason for the invitation was that there was a problem with the overall production system, we decided to issue an order to suspend operations for manufacturing and company-wide sales at the Toyama Daiichi Plant next month.
This is the first time that the prefecture has issued a business suspension order to Nichi-Iko, and we are making adjustments so that the period of the business suspension order for the Toyama Daiichi Plant will be approximately one month.
Nichi-Iko said in an interview with NHK that "I cannot comment because I have not received an order to suspend operations at this time" and "I deeply apologize for the inconvenience caused to patients and medical personnel due to voluntary recall of many items. I would like to work on preventing recurrence in the future. "
Regarding low-priced generic drugs, a drug manufacturer in Fukui Prefecture, which manufactured on February 9, has been ordered to suspend operations even for the problem that a component of a sleep-inducing agent is mixed in a therapeutic drug such as athlete's foot.