Reported Aug 13, 2014 · Terminated
Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion…
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), 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
- Lots
10002-100006-1Exp 08/1410003AExp 11/1410004AExp 02/1510005A10005AR10007A10006AExp 07/15and 10008AExp 08/15
- Lots
- Amount recalled
- 96,506 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Using this product could cause serious injury, illness or death — stop using it now.
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