Sanofi-Aventis Korea has initiated a voluntary recall of some batches of Eloctate (efmoroctocog alfa), a hemophilia A treatment, from the Korean market.
According to the Ministry of Food and Drug Safety, the company has recently filed a recall plan for specific batches of Eloctate (250 IU, 1000 IU) with manufacturing numbers SP2103, SP2109, and SP2211, citing a labeling error in the expiration date.
Sanofi-Aventis Korea issued a notice on its website regarding the recall, instructing distributors and healthcare organizations in possession of the affected drug “to promptly cease selling it and return it to the designated individual at Sanofi-Aventis Korea overseeing the recall process.”
Eloctate is a recombinant clotting factor therapy to treat hemophilia A, a genetic disorder characterized by prolonged or spontaneous bleeding resulting from a deficiency or defect in blood clotting factor VIII.
It distinguishes itself through an extended half-life compared to existing factor VIII therapies, achieved by offering both factor VIII and an Fc fusion protein.
Sanofi-Aventis Korea released Eloctate in the Korean market in June 2020.
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