|Product||Lot||Expiration Date||First Ship Date||Last Ship Date|
|Soliris® (eculizumab) 300 mg/30 mL Concentrated solution for intravenous infusion only NDC 25682-001-01||10010A||Oct. 31, 2015||Oct. 11, 2013||Nov. 1, 2013|
|10001-1||July 31, 2014||June 4, 2012||May 8, 2013|
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. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
Safe Harbor StatementThis news release includes forward-looking statements relating to continued adequacy of supply of Soliris, and identification and correction of the cause of the visible particles. These statements are subject to risks, uncertainties and other factors, including risks related to continuous product inventory and supply, the uncertainties involved in manufacturing of biologic products, and whether the FDA, EMA or other international regulatory authorities decide to take corrective or disciplinary actions against Alexion, as well as the risks that are described in detail in Alexion’s Quarterly Report on Form 10-Q for the quarter ended Sept. 30, 2013, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Alexion, and Alexion assumes no duty or obligation to update or revise any such forward-looking statements or any other statement in this report.