Alexion Recalls Soliris Vials Due to Visible Particulate Matter
Alexion Pharmaceuticals is recalling 21,661 vials of Soliris (eculizumab) because they failed an appearance test for visible particles.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
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
- 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.
Lot numbers (4)
- Lot #: 10001-1
- Exp 07/14
- 10010A
- Exp 10/15
UPCs (1)
- 325682001016
Distribution
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