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Prescribed for 364 people, mixed in process not approved
December 12, 2020 7:30 am
Kobayashi Kako Headquarters, which promotes voluntary recovery by mixing components of sleep-inducing agents into the tablets it manufactures. Health damage occurs one after another across the country = December 11, Yachi, Awara City Fukui prefecture
Kobayashi Kako (Headquarters: Awara City, Fukui Prefecture) identified 364 patients nationwide who were prescribed the oral antifungal agent Itraconazole Tablets 50 “MEEK”, which is voluntarily recovered with a sleep-inducing agent component mixed, December 11. Revealed. At midnight the same day, a total of 133 people were reported to Fukui prefecture for health problems such as loss of consciousness, memory loss and dizziness, and there were 16 accidents while driving a car. So far, 34 people have been hospitalized. The company announced the same day that a patient who took the tablet died.
According to Fukui Prefecture, contamination with components of sleep-inducing agents may have occurred in a manufacturing process that has not been approved by the Ministry of Health, Labor and Welfare. When adding the raw materials, the person in charge confused the main component with the component of the sleep-inducing agent “Hydrate of lil mazafone hydrochloride.” According to company regulations, this job must be confirmed by a couple of people, but at that time there was only one person in charge.
According to the company, the amount mixed per tablet was 2.5 times the maximum dose normally used for sleep-inducing agents.
The mixed tablets are not distributed in Fukui prefecture and no damage has been reported. Prescription patients have already contacted all 31 prefectures, including Osaka, Tokushima, and Gifu, asking them to stop taking the drug and continue to collect them through medical institutions and pharmacies.
Itraconazole tablets are medicines used to treat nail worms and yeast infections. The company began voluntary collection on day 4, targeting 929 boxes containing 100 tablets that were found to be contaminated. On day 7 it was found that the process had not been approved and the objective of voluntary collection was extended to all batches of itraconazole tablets.
⇒ Medical personnel in Fukui prefecture “damage trust in drugs”
Fukui prefecture will also carry out additional on-site inspections to confirm that the company’s other products are free from defects in the manufacturing process.
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