February 15, 2013
Gilead Sciences, a bio-pharmaceutical company, has voluntarily recalled Vistide®, a product used to treat cytomegalovirus in AIDS patients, because "particulate matter" was discovered in some vials of the drug. The description of the contaminated product reads: Vistide® -- cidofovir injection, NDC #61958-0101-1, Lot # B120217A, Expiration Date May 2015. Gilead distributed Vistide Lot #B120217A to wholesalers and hospital and retail pharmacies in the United States, Canada, and Europe.
Gilead has contacted all customers by email and letter and will arrange for the return of Vistide product lot # B120217A. U.S. customers should call Stericycle at 1-888-965-5791, Monday to Friday, 8:00 a.m. to 8:00 p.m. Eastern Time to obtain information on returning Vistide product lot # B120217A.
Although Gilead has not reported any complaints "attributable" to the particulate matter in this Vistide lot, the effects of the particulate matter could be severe, depending on the amount injected, size of the particles, and patient condition. Vistide is a colorless, "sterile, hypertonic aqueous solution" that is packaged in glass vials and usually dispensed in hospitals and health care offices. Health care providers should inspect the lot numbers before injecting Vistide, and they should not inject Vistide Lot # B120217A.
Patients should report problems related to this product to their health care providers.
Health professionals and pharmacists may 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 to ask questions or report adverse reactions.
The U.S. Food and Drug Administration is aware of Gilead's recall of Vistide Lot # B120217A. Patients, health professionals, and pharmacists may report adverse reactions online, by mail, or via fax:
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.