Soliris — Class I drug recall D-1512-2014
Terminated recall by Alexion Pharmaceuticals, Inc., reported 2014-08-13, distributed nationwide. Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labe
| Recall number | D-1512-2014 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alexion Pharmaceuticals, Inc., Cheshire, CT, United States |
| Recall initiated | 2014-06-02 |
| Classified | 2014-08-05 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2015-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 96,506 vials |
| Reason classes | labeling, specification failure |
| NDC | 25682-0001, 25682-0001-01 |
| Lot numbers | 00006-1, 02/15, 07/15, 08/14, 08/15, 10002-1, 10003A, 10004A, 10005A, 10005AR, 10006A, 10007A, 10008A, 11/14 |
Product
Soliris (eculizumab), 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: Product failed the appearance for the presence of visible particles under labeled storage condition.
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-1512-2014. 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.