CLASS I Drug recall · Reported 13 Aug 2014 · FDA Enforcement Report
Soliris (eculizumab), 300 mg/ (10 mg/mL) Single-Use Vial recalled
Alexion Pharmaceuticals is recalling Soliris (eculizumab), 300 mg/ (10 mg/mL) Single-Use Vial, distributed nationwide in the US. The recall was initiated on 2 Jun 2014 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1512-2014
- FDA event ID
- 68401
- Recalling firm
- Alexion Pharmaceuticals, Cheshire, CT
- Brand
- Soliris
- Manufacturer
- Alexion Pharmaceuticals Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Jun 2014
- FDA classified
- 5 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jun 2014 | Recall initiated by company | |
| 5 Aug 2014 | Classified by FDA | +64 days |
| 13 Aug 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Soliris (eculizumab), 300 mg/ (10 mg/mL) Single-Use Vial recalled?
Yes. Alexion Pharmaceuticals recalled Soliris (eculizumab), 300 mg/ (10 mg/mL) Single-Use Vial on 2 Jun 2014. The recall is Class I and its status is Terminated. Recall number D-1512-2014.
Why was it recalled?
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Which lots are affected?
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
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Alexion Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Soliris (eculizumab) Concentrated Solution recalledSoliris | Alexion Pharmaceuticals | Particulate Matter | Nationwide |
Other Eculizumab recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Soliris (eculizumab) Concentrated Solution recalledSoliris | Alexion Pharmaceuticals | Particulate Matter | Nationwide |