Gilead Issues a Voluntary Recall of One Lot of Vistide® (Cidofovir Injection) Due to Presence of Particulate Matter

  Gilead Issues a Voluntary Recall of One Lot of Vistide® (Cidofovir
  Injection) Due to Presence of Particulate Matter

Business Wire

FOSTER CITY, Calif. -- February 15, 2013

Gilead Sciences, Inc. (Nasdaq: GILD) today announcedit is voluntarily
recallinglot 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^®
                        61958-0101-1   B120217A   May 2015
(cidofovir injection)
                                                  

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. The lot number, located on the
product label on the side of the vial, is B120217A. This lot of Vistide was
distributedin the United States, Canada and Europe to wholesalers and
hospital and retail pharmacies. The recall does not affect any other Gilead
products.

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
contactGileadMedical 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 GileadMedical 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.

About Gilead Sciences

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.

For more information on Gilead Sciences, please visit the company’s website at
  www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead
             Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact:

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Erin Rau, 650-522-5635 (Media)
 
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