Soliris — Class I drug recall D-1049-2014
Terminated recall by Alexion Pharmaceuticals, Inc., reported 2014-02-05, distributed nationwide. Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
| Recall number | D-1049-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alexion Pharmaceuticals, Inc., Cheshire, CT, United States |
| Recall initiated | 2013-11-04 |
| Classified | 2014-01-30 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | JM |
| Quantity | 21,661 vials |
| Reason classes | specification failure |
| NDC | 25682-0001, 25682-0001-01 |
| Lot numbers | 07/14, 10/15, 10001-1, 10010A |
Product
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
Reason for recall
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1049-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.