Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

Summary

Company Announcement

FOR IMMEDIATE RELEASE – Foster City, Calif., September 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company’s investigation.

Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material. The glass particulate can potentially travel, through the blood vessels, to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead has not received any reports of adverse events related to this recall.

Veklury® (remdesivir) for Injection 100 mg/vial is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are:

• Hospitalized, or
• Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death

Veklury® (remdesivir) for Injection 100 mg/vial may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.

The product being recalled is the lyophilized form of Veklury® (remdesivir) for Injection 100 mg/vial packaged in single dose clear glass vials in powder form. Veklury lot # 47035CFA was distributed nationwide in the United States, beginning 16 July 2024. NDC, lot, expiration date and distribution dates can be found in the table below.

Gilead is notifying its distributors and customers via UPS next day air mail to pharmacies and is facilitating the return of any remaining vials from the affected lot. Facilities that have Veklury® (remdesivir) for Injection 100 mg/vial which is being recalled should stop using the affected lot and return the product vials per the instructions in the letter.

Consumers and healthcare providers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474 Monday to Friday 5am – 6pm PST or through their website at www.askgileadmedical.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Note regarding forward-looking statements