  |
Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles
AUDIENCE: Hematology, Pharmacy
ISSUE: Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles. At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level.
The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immunogenicity and thromboembolic events. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the affected lots. As previously stated, Alexion does not anticipate any interruption to patient supply of Soliris.
BACKGROUND: The product is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare disorders. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product was last shipped on Nov. 1, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level. Soliris (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-01, Lot number: 10010A and 10001-1.
RECOMMENDATION: Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately by calling 1-888-SOLIRIS (888-765-4747).
Alexion will replace any recalled vials of Soliris. Unaffected lot numbers can continue to be used according to the instructions for use. Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747.
Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
