Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability

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The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Fresenius Kabi USA, LLC (Fresenius Kabi), for Fresenius Propoven 2% Emulsion. FDA revoked the Authorization on May 10, 2022, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.