Two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion were recalled because they were found to contain visible particles. 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.
Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare disorders. The manufacturer, Alexion, and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product was last shipped on November 1, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level. Alexion does not anticipate any interruption to the patient supply of Soliris.
The two affected lots were distributed nationwide. Lot 10010A, expiration date October 31, 2015, was shipped between October 11, 2013, and November 1, 2013. Lot 10001-1, expiration date July 31, 2014, was shipped between June 4, 2012 and May 8, 2013.
Alexion believes that it has identified the filling process step that resulted in the presence of the visible particles and implemented the change necessary to correct the issue. To date, visible particles have not been observed in other lots of Soliris distributed in the U.S.
See the Recall
See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication