Reported Feb 5, 2014 · Terminated
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use…
Alexion Pharmaceuticals, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alexion Pharmaceuticals, Inc. · 352 Knotter Dr · Cheshire, CT · 06410-1138
Is this the product you have?
- Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only
- Manufactured byAlexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6
- Lot codes and dates
Lot #: 10001-1Exp 07/1410010AExp 10/15
- Amount recalled
- 21,661 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Using this product could cause serious injury, illness or death — stop using it now.
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