FDA Drug recall D-1512-2014
Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT…
- FDA Drug
- Class I
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class I recall of Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT… by Alexion Pharmaceuticals, citing presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1512-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-06-02 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Alexion Pharmaceuticals |
| Distribution | US |
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
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Identifiers
| upc | 325682001016 |
|---|---|
| ndc | 25682-001-01 |
| code_info | 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 |
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-1512-2014%22
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