Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Gilead Sciences, Inc. is voluntarily recalling lot B120217A of Vistide® (cidofovir injection) to the user level due to the presence of particulate matter found in some vials of this lot. Gilead is not currently aware of any complaint attributable to the particles.
BACKGROUND: 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, B120217A,is located on the product label on the side of the vial.
RECOMMENDATION: Gilead has notified its distributors and customers by e-mail and recall letter and is arranging for return of all recalled product. Before injecting Vistide, healthcare providers should inspect the product 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), Monday to Friday 8:00 a.m. to 5:00 p.m. Pacific Time.
Healthcare professionals and patients 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
[02/15/2013 - Firm Press Release]