Class I · High risk
Soliris (eculizumab)
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Soliris (eculizumab)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
25682-0001-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Soliris Eculizumab NDC 25682-0001 |
300 mg/30mL | Injection, Solution, Concentrate Intravenous |
Alexion Pharmaceuticals Inc. | Rx |
- Recalling firm
- Alexion Pharmaceuticals, Inc.
- NDC code
- 25682-001-01
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1512-2014 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Alexion Pharmaceuticals, Inc.
All 2014 recallsOther particulate / foreign matter recalls from 2014
All particulate / foreign matter recalls
Class II · Moderate risk
Children's Loratadine Syrup
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
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