Gilead Sciences Recalls AIDS Drug Vistide® For Possible Contamination

Bio-pharmaceutical company Gilead Sciences, Inc. has announced a voluntary recall of one of it’s products, Vistide® (cidofovir injection), lot # B120217A, due to the presence of particulate matter found in some vials of this lot.

The product description is as follows, Vistide® – cidofovir injection, NDC # 61958-0101-1, Lot # B120217A, Expiration Date May 2015.

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 Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

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.

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

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, 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.

Jim Donahue