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Recall: Soliris

by Elizabeth Davis on June 9, 2014 at 10:58 am

Alexion Pharmaceuticals has announced a voluntary recall for several lots of Soliris (eculizumab) due to visible particles in the 300 mg/30 mL (10 mg/mL) concentrated solution for intravenous infusion.

Soliris is a specialty drug use to treat two rare conditions: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

The particles have only been found in one lot, 10007A, however, Alexion is including several other lots where the vials were filled with the same components. Lot 10007A has the NDC number 25682-001-01 and expires July 2015. You can find a list of the rest of the recalled lots here.

The affected Soliris vials have been distributed to wholesalers, hospitals, and pharmacies. Alexion is arranging for the return and replacement of any affected products; if you have any Soliris from an affected lot, stop using it and call 1-888-SOLIRIS.

For the details on the current recall, you can find the FDA recall announcement here.


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