FDAFDA · Food and drugs·Recall number D-1049-2014
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 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 February 5, 2014 · Recall initiated: November 4, 2013
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: Failed the appearance test for the presence of visible particles.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- SOLIRIS
- Manufacturer
- Alexion Pharmaceuticals, Inc.
- Distributor
- Nationwide, Puerto Rico, Jamaica, and Grenada.
- UPC
- 325682001016
- Lot
- Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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