Gilead Initiates Nationwide Voluntary Recall of a Single Lot of Veklury (Remdesivir) 100 mg/vial Due to Detection of a Glass Particle

Summary

Company Announcement

FOR IMMEDIATE RELEASE – Foster City, Calif., September 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced the voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial to the consumer level. Gilead confirmed the presence of a glass particle in the vial after receiving a customer complaint.

Risk Statement: Ingesting an injectable product containing glass particles may cause local irritation or swelling due to the foreign material. Glass particles may travel through blood vessels causing blockages in various organs, potentially leading to severe health issues, including stroke or death. As of now, there have been no reported adverse events related to this recall.

Veklury® (remdesivir) for Injection 100 mg/vial is approved for treating COVID-19 in adults and pediatric patients (birth to under 18 years) weighing at least 1.5 kg who are:

• Hospitalized, or
• Not hospitalized but at high risk of progressing to severe COVID-19, including hospitalization or death

This product can only be administered in settings where healthcare providers can quickly access medications for severe reactions, like anaphylaxis, and are equipped to activate emergency medical services when necessary.

The recalled product is the lyophilized version of Veklury® (remdesivir) for Injection 100 mg/vial in single-dose clear glass vials. Lot # 47035CFA was distributed nationwide starting July 16, 2024. Details regarding the NDC, lot, expiration date, and distribution dates are listed in the table below.

Gilead is reaching out to its distributors and customers via next-day UPS air mail and is managing the return of any remaining vials from the affected lot. Facilities with the recalled Veklury® (remdesivir) for Injection 100 mg/vial should cease using the impacted lot and follow the return instructions outlined in the notification letter.

For inquiries regarding the recall, consumers and healthcare providers can contact Gilead Medical Information at 1-866-633-4474, available Monday to Friday 5 am – 6 pm PST, or through their website at www.askgileadmedical.com. Users experiencing any issues related to this drug should consult their physician or healthcare provider.

Reports of adverse reactions or quality concerns related to this product can be submitted to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.

• Report online here.
• Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, fill it out and send it to the address on the provided pre-addressed form or fax to 1-800-FDA-0178.

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