REGULATORY INTELLIGENCE·Recall
Fresenius Kabi Fosaprepitant Recall: Excipient Labeling Error Impacts US Supply Chain
Fresenius Kabi USA, LLC initiated a Class III recall for 63,067 vials of Fosaprepitant for Injection due to an excipient labeling error. The carton incorrectly stated edetate disodium quantity, highlighting critical regulatory compliance and supply chain oversight needs. This event underscores the imperative for robust quality control and accurate product information for pharmaceutical procurement and regulatory teams.
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