Gilead Sciences, Inc. (Nasdaq: GILD) today announced it 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.
|Product Description||NDC||Lot #||Expiration Date|
|Vistide® (cidofovir injection)||61958-0101-1||B120217A||May 2015|
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