Alexion Pharmaceuticalstoday announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. As previously stated, Alexion believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process. Alexion does not anticipate any interruption to patient supply. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S. No safety risks to patients who have received Soliris have been identified. There is no financial impact from the voluntary recall announced today.
The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A. Following this voluntary recall, there will no longer be Soliris in the U.S. manufactured using the previously identified process component that Alexion believes resulted in the stability failure.
The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. 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 product from the affected lot was last shipped on October 29, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level.
Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening 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 from the identified lots was last shipped on October 30, 2013, there is anticipated to be little, if any, material from these lots still remaining in commercial distribution.
The following table lists the lots that are being recalled, which were distributed in the U.S. to wholesalers, hospitals and pharmacies:
|Product||Lot||Expiration Date||First Ship Date||Last Ship Date|
Soliris ® (eculizumab)
Concentrated solution for
|10007A||July 2015||June 17, 2013||Oct. 29, 2013|
|10002-1||Aug. 2014||Sept. 6, 2012||Sept. 9, 2013|
|00006-1||Aug. 2014||Oct. 12, 2012||May 15, 2013|
|10003A||Nov. 2014||March 28, 2013||Oct. 3, 2013|
|10004A||Feb. 2015||Feb. 4, 2013||Sept. 24, 2013|
|10005A||July 2015||May 15, 2013||Oct. 28, 2013|
|10005AR||July 2015||Sept. 23, 2013||Sept. 26, 2013|
|10006A||July 2015||July 8, 2013||Oct. 24, 2013|
|10008A||Aug. 2015||Aug. 16, 2013||Oct. 30, 2013|
Alexion is notifying its distributors and customers by letter being sent via Federal Express and is arranging for replacement of all recalled products. 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), Monday-Friday from 8:30 a.m. to 5:00 p.m. Eastern Time (ET).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, Monday-Friday from 8:30 a.m. to 5:00 p.m. ET. 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.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular mail or fax: Download form 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.