Wednesday, January 15, 2014

Nationwide Recall of Two Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion

From the FDA, and update on this recall: 

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN)today is providing further 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.

The product is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare disorders. 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 Nov. 1, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level.

The following table lists the two affected lots, which were distributed nationwide.

ProductLotExpiration DateFirst Ship DateLast Ship Date
Soliris® (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-0110010AOct. 31, 2015Oct. 11, 2013Nov. 1, 2013
10001-1July 31, 2014June 4, 2012May 8, 2013

As previously disclosed, 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.