2020/12/18

Yakuji Nippo

Carried out On-site Investigation of Kobayashi Kako ‐ Health Problems Expanded to 128 Cases


株式会社薬事日報社から許諾を受けて、株式会社シーエムプラスが英語に翻訳しております。
オリジナルの正式言語は日本語であり、内容および解釈については日本語が優先されます。
With permission from Yakuji Nippo, Limited, CM Plus Corporation translated into English.
The original article is authored in Japanese, and the Japanese shall prevail in meaning in terms of content and interpretation.

【Fukui Prefecture】
Carried out On-site Investigation of Kobayashi Kako ‐ Health Problems Expanded to 128 Cases

December 14th, 2020

On December 9, 2020, the Fukui Prefectural government carried out an on-site investigation at Kobayashi Kako over the issue of contamination of oral antifungal drug "itraconazole" it manufactures and markets with a sleep inducer, for possible violation of the Pharmaceuticals and Medical Devices Act. The inspection was carried out after the company and Meiji Seika Pharma, which jointly sells the products, completed identification of the patients who were prescribed the medicine and necessary communication including discontinuation of use of the drug. As of 17:00, December 10, 128 cases of health problems including serious ones had been reported and the number is thought to be the highest number of reports of pharmaceutical-related health problems caused by improper manufacturing control. Depending on the results of the investigation, the company may be subject to administrative penalties.

The drug was contaminated with 5 mg of rilmazafone hydrochloride hydrate, a sleep-inducing ingredient, per tablet. If the drug has taken 4 times a day, the dosage would be 20 mg; this means that the drug was contaminated with the ingredient as much as 10 to 20 times the usual daily dosage.

(Continue to the next)


For this translated article in English, CM Plus Corporation shall have the copyright.
Unauthorized reproduction of posted articles, photos, diagrams, etc. is prohibited.
Copyright © 2020 LSMIP office / CM Plus Singapore Pte. Ltd.

A Series of Articles

About the Author

Related Articles

No information is found.

Digital Health
U.S. eHealth Journal

Vol. 81 (Issued at 2023/1/24)

ジャーナル81号のトピックは、Alex Therapeutics社(肺線維症患者向けDTx)、PatientsLikeMe(患者SNSコミュニティ)、LetsGetChecked社(在宅診断テスト)、Sonde Health社(音声バイオマーカー)、Eargo社(OTC補聴器) など

Most Popular

1

Online Roundtable Discussion Among Clinical Doctors 【Part 5】

LSMIP Editorial Office

2

Aevice Health Develops Wearable Stethoscopes for Chronic Respiratory Disease Patients

Kazunori Seto M.D.

3

Interview with Dental Start-up SQRIE - About Social Challenges and Services it Offers

Megumi Kamo DDS, PhD.

4

Mitsutoshi Yamada

5

MSA Partners, LLC

Press Room

Placeholder