Soliris Injection, Solution, Concentrate
FDA Recall NDC 25682-001
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Soliris (NDC 25682-001). A significant event, classified as Class I, was initiated on Jun 02, 2014 by Alexion Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Jun 02, 2014
Aug 13, 2014
96,506 vials
Recall Profile & Regulatory Data
Event ID
68401
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Alexion Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
May 29, 2015
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
25682-001-01Product
Class I Terminated
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Nov 04, 2013
Feb 05, 2014
21,661 vials
Recall Profile & Regulatory Data
Event ID
66771
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Alexion Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, Jamaica, and Grenada.
Termination Date
Mar 02, 2015
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.
Batch or Lot Expiration Information
Lot# : 10001-1, Exp 07/14; 10010A, Exp 10/15
Affected Packages Involved in this Recall
25682-001-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
