Cidofovir Injection (Vistide)
February 20, 2013
Gilead initiated a voluntary recall of one lot (Lot B120217A) of cidofovir injection (Vistide). Cidofovir injection is labeled for treatment of cytomegalovirus retinitis in patients with AIDS. Some of the vials in the affected lot were found to contain particulate matter. This lot was distributed to wholesalers, hospital pharmacies, and retail pharmacies in the United States, Canada, and Europe. The lot number and expiration date can be found on the vial label. Information for the affected product is listed below.
- Vistide (cidofovir injection) 75 mg/mL, 375 mg/5mL single dose vial, NDC 61958-0101-01, Lot # B120217A , expiration date: May 2015
Inspect the vials before injecting cidofovir. Do not administer any product from the affected lot. Injecting products with particulate matter can cause severe adverse effects in patients.
Distributors and customers have been notified to return all recalled products by calling Stericycle at 1-888-965-5791, weekdays from 8AM to 8PM Eastern Standard Time. Patients or health care professionals can report adverse events to Gilead at 1-800-445-3235 [Option 2], weekdays from 8AM to 5PM Pacific Standard Time. Adverse events can also be reported to FDA online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-322-1088, by fax at 1-800-FDA-0178, or by mailing the completed form. The MedWatch form is available at http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf. Healthcare professionals may call Gilead Medical Information (1-800-445-3235) for additional information on the recall.
Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
- Photo of the packaging labels:
February 20, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.