Message regarding Hydroxyprogesterone Caproate Injection

On April 6, 2023, FDA withdrew its approval of generic Makena (hydroxyprogesterone caproate injection) manufactured by Eugia US. Eugia US, therefore, is no longer selling or distributing the drug. The company is conferring with FDA about how to handle any returns, so please contact us before initiating any return of generic Makena manufactured by us. Please refer to FDA’s website to obtain additional information regarding the agency’s position on inventory currently in distribution. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information#CDER-statements