June 2, 2014 — Alexion Pharmaceuticals Inc. is recalling Soliris (eculizumab) 300-mg/30-mL intravenous solutions due to the presence of visible particles that were detected in a single lot during stability testing.
This is the third time Alexion has recalled Soliris, the company’s only FDA-approved drug. The company has been plagued by manufacturing problems. In March 2013, the FDA issued a warning letter for their plant in Rhode Island due to a problem with bacterial contamination. Alexion says those problems have been addressed.
The new problems have been linked to a manufacturing process component during vial filling. The affected lot is #10007, but Alexion is also recalling lots that were manufactured using the same process: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A.
The products were last shipped on October 29, 2013. Alexion believes there is little, if any, inventory remaining in commercial distribution.
According to a recall from the U.S. Food and Drug Administration (FDA), there have been no complaints or injuries linked to the products, but they could potentially cause 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 used to treat two rare but serious conditions, paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). These conditions can cause severe damage to the kidneys, heart, and brain.
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