Recall – visible particles in Soliris (Eculizumab) concentrated solution for intravenous infusion

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#IVTEAM #Intravenous products: FDA report “Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles. At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level.

The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immunogenicity and thromboembolic events. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As previously stated, Alexion does not anticipate any interruption to patient supply of Soliris.”

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