June 2, 2014 — The U.S. Food and Drug Administration (FDA) has announced a voluntary recall for Soliris (eculizumab), a 300-mg/30-mL intravenous (IV) solution that may be contaminated with visible particulate matter.
Alexion has already recalled Soliris twice to address manufacturing problems. The FDA sent the company a warning letter in March 2013 after finding bacterial contamination in products manufactured at a facility in Rhode Island. Alexion hired a team of experts and says those problems have been fixed.
Alexion says the new problems are associated with a manufacturing process component during vial filling. The problem was observed in lot #10007, but Alexion is recalling all products that were manufactured using the same process. These lots include 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A.
The last time the products were shipped was October 29, 2013. Alexion ships small quantities of Soliris that are timed to individual patient infusions. Therefore, it is likely that most of the recalled products have already been used or discarded.
The FDA has not received any complaints or reports of injury linked to the products. However, there is a possible risk of life-threatening side effects:
“The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.”
Soliris is approved to treat two conditions that are very rare — paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). People who develop these conditions are at risk of damage to the kidneys, heart, and brain.
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