Alexion Recalls Soliris Vials Due to Visible Particulate Matter
Alexion Pharmaceuticals is recalling 96,506 vials of Soliris (eculizumab) because the product failed appearance tests for visible particles under labeled storage conditions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Alexion Pharmaceuticals, Inc. is recalling 96,506 vials of Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial. The recall was initiated because the product failed the appearance test for the presence of visible particles under labeled storage conditions.
The affected lots include 10002-1, 00006-1 (Exp 08/14); 10003A (Exp 11/14); 10004A (Exp 02/15); 10005A, 10005AR, 10007A, 10006A (Exp 07/15); and 10008A (Exp 08/15). The product was distributed nationwide and in Puerto Rico.
Soliris is a prescription-only intravenous medication manufactured by Alexion Pharmaceuticals, Inc. in Cheshire, CT. The source text does not specify specific instructions for consumers or healthcare providers regarding the disposal or return of the recalled product.
The recalled product
- Product
- SOLIRIS (ECULIZUMAB)
- Brand
- SOLIRIS
- Manufacturer
- Alexion Pharmaceuticals, Inc.
- Category
- Drug — Prescription Injectable
- Hazard
- Affected units
- 96,506
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 (14)
- Lots: 10002-1
- 00006-1
- Exp 08/14
- 10003A
- Exp 11/14
- 10004A
- Exp 02/15
- 10005A
- 10005AR
- 10007A
- 10006A
- Exp 07/15
- and 10008A
- Exp 08/15
UPCs (1)
- 325682001016
Distribution
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