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June 2, 2014

Alexion recalls Soliris lots for second time in a year

Alexion website

Cheshire drug manufacturer Alexion Pharmaceuticals said it has initiated a voluntary nationwide recall of nine lots of its Soliris drug because of the presence of visible particulate matter in a single lot — 10007A — shipped from June to Oct. 2013.

The company believes there is very little inventory of the lot left at the hospital or user level.

The affected lot was distributed only in the United States and no safety risks to patients have been identified, Alexion said. The company also expects no financial impact from the recall.

Alexion’ share price was down eight-tenths of a percent in pre-market trading.

Alexion said it believes the problem was related to a process component during vial filling. The company included eight additional lots in the recall because they were produced with the same process component.

Alexion initiated similar recalls in November and August.

Particulate matter in the injectable drug presents a potential risk of immune reaction and blood clots, Alexion said.

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