Alexion Recalls More Soliris Due to Persistent Particle Problem

June 6, 2014

Alexion is pulling more of its flagship product Soliris from the market due to visible particles that arose from a manufacturing problem, its third recall in less than a year.

The drugmaker voluntarily recalled nine lots of the rare blood disease drug after visible protein particles were discovered in a single lot during periodic stability testing, the company said.

The move follows a voluntary recall announced in November 2013 and another in August 2013 due to a similar particulate problem. While the particles were discovered in one lot, Alexion is recalling the other eight because they were made using the same process component during vial filling that was the culprit of earlier recalls, the company said.

“Alexion believes it has identified the process component that result in the presence of the visible particles and implemented a change to the process,” it noted.

The drugmaker declined to elaborate on specifics, but noted the problems were tied to a third-party contractor, one of three used by the drugmaker. “We replaced the single process step with this one third-party vial filler,” Alexion spokeswoman Kim Diamond said.

Alexion hasn’t received any adverse safety reports from the product. But it stressed that particulate in a parenteral drug could block the flow of blood in vessels, which could lead to life-threatening blood clots. The particulates also could create an immune reaction.

The company said it doesn’t anticipate any supply disruptions due to the recall. The drug, which is Alexion’s only approved product, treats the rare blood disease paroxysmal nocturnal hemoglobinuria and genetic disease atypical hemolytic uremic syndrome, Diamond said the company expects that the current and prior Soliris recalls will cost the company between $10 and $25 million.

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