Prevention of Rare Diseases and Orphan Drug Act Article 30

When an orphan drug is not recalled within the deadline set by the central competent authority as stipulated in Article 20, a fine of NT$ 30,000 to NT$ 150,000 shall be imposed, with consecutive penalties to be levied until the recall is made.
中文原文 罕見疾病防治及藥物法第30條
違反主管機關依第二十條規定令其限期回收之命令者,處新台幣三萬元以上十五萬元以下罰鍰,並按次連續處罰至回收為止。

English translation for reference only; the Chinese text prevails. Not legal advice.