医薬品医療機器等法に基づく行政処分を行いました｜厚生労働省
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医薬品医療機器等法に基づく行政処分を行いました｜厚生労働省
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This page announces administrative actions taken against Sawai Pharmaceutical's Kyushu plant regarding improper quality testing methods for the medication Teprenone Capsule 50mg. The company used different testing procedures than those approved, including replacing capsules before conducting dissolution tests. Osaka and Fukuoka prefectures issued business improvement orders, and the Ministry of Health, Labour and Welfare ordered a change in the responsible person for manufacturing and sales. The incident poses minimal risk to drug efficacy and safety, with no adverse health reports.
