Gilead Sciences Inc. is voluntarily recalling lot B120217A of Vistide (cidofovir injection) at the user level due to the presence of particulate matter found in some vials of this lot.
Effects from intravenous injection of product with particulate matter can vary depending on the amount of particulate matter injected into the patient, the size of the particles and the patient's underlying medical condition, and can be severe. Gilead is not currently aware of any complaint attributable to the particles.
Vistide is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear, colorless and supplied in clear glass vials. It is typically given in a hospital setting or in a doctor's office. The lot number, located on the product label on the side of the vial, is B120217A. This lot of Vistide was distributed in the United States, Canada and Europe to wholesalers and hospital and retail pharmacies. The recall does not affect any other Gilead products.
Gilead has notified its distributors and customers by e-mail and recall letter and is arranging for return of all recalled product.
In the United States, for information on how to return Vistide product with lot number B120217A, call Stericycle at 1-888-965-5791, Monday to Friday 8:00 a.m. to 8:00 p.m. Eastern Time.
Before injecting Vistide, the product should be inspected and any product with lot number B120217A should not be injected.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using Vistide. Healthcare professionals and pharmacists with questions regarding this recall can contact Gilead Medical Information at 1-800-GILEAD-5 (1-800-445-3235) [Option 2], Monday to Friday 8:00 a.m. to 5:00 p.m. Pacific Time.
Adverse reactions or quality problems experienced with the use of this product may be reported to Gilead Medical Information at 1-800-GILEAD-5 (1-800-445-3235) [Option 2], Monday to Friday 8:00 a.m. to 5:00 p.m. Pacific Time.
Adverse reactions can also be reported directly 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Date: February 15, 2013
Source: Gilead Sciences Inc.