Alexion Recalls Soliris Vials Due to Visible Particulate Matter

Plain-English summary

Alexion Pharmaceuticals, Inc. is recalling 21,661 vials of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL). The recall was initiated because the product failed an appearance test for the presence of visible particles.

The affected product is distributed nationwide, as well as in Puerto Rico, Jamaica, and Grenada. The specific lots involved are 10001-1 (expiration date 07/14) and 10010A (expiration date 10/15). The product is a prescription-only medication manufactured by Alexion Pharmaceuticals, Inc., in Cheshire, CT.

Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions. The recall is classified as FDA Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product

SOLIRIS (ECULIZUMAB)

Brand

SOLIRIS

Manufacturer

Alexion Pharmaceuticals, Inc.

Category

Drug — Prescription Drug

Hazard

• particulate-matter

Affected units

21,661

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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