Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL)...
FDA Recall #D-1049-2014 — Class I — November 4, 2013
Product Description
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.
Reason for Recall
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Recalling Firm
Alexion Pharmaceuticals, Inc. — Cheshire, CT
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
21,661 vials
Distribution
Nationwide, Puerto Rico, Jamaica, and Grenada.
Code Information
Lot #: 10001-1, Exp 07/14; 10010A, Exp 10/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated