FDA Drug recall D-1049-2014
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufact…
- FDA Drug
- Class I
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class I recall of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufact… by Alexion Pharmaceuticals, citing presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1049-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-11-04 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Alexion Pharmaceuticals |
| Distribution | US |
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
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Identifiers
| upc | 325682001016 |
|---|---|
| ndc | 25682-001-01 |
| code_info | Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1049-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.