FDAFDA · Food and drugs·Recall number 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 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
Published August 13, 2014 · Recall initiated: June 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- SOLIRIS
- Manufacturer
- Alexion Pharmaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico
- UPC
- 325682001016
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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