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FDA openFDA Drug Enforcement (recalls)·· 7 天前精选AI 评分93

Formoterol Fumarate 吸入溶液因杂质/降解超标被召回

Formoterol Fumarate Inhalation Solution, 20mcg/2mL, packaged in cartons of 30 individually wrapped vials (NDC 76204-030-01) and 60 individually wrapped vials (NDC 76204-030-02), Rx only, Manufactured for and by: Ritedose Pharmaceuticals, LLC, Columbia, SC

AI 导读

FDA 召回记录显示,Ritedose Pharmaceuticals, LLC 生产的 Formoterol Fumarate Inhalation Solution(20mcg/2mL,NDC 76204-030-01 及 76204-030-02)因 Failed Impurities/Degradation Specification 被召回;具体召回级别、影响批次及后续措施未披露。

推荐理由

FDA 召回记录,涉及 Formoterol Fumarate 吸入溶液杂质/降解超标。

来源:FDA openFDA Drug Enforcement (recalls) · api.fda.gov