November 2013 FDA Recall Soliris by Alexion Pharmaceuticals, Inc.
D-1049-2014 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Alexion Pharmaceuticals, Inc. on November 4, 2013 for the product Soliris. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1049-2014
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
11-04-2013
02-05-2014
21,661 vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alexion Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Puerto Rico, Jamaica, and Grenada.
03-02-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
