WASHINGTON, D.C. — Gilead Sciences, Inc. (Nasdaq: GILD) has announced a voluntary recall of one lot of its COVID-19 treatment drug, Veklury® (remdesivir) for Injection 100 mg/vial, following the discovery of a glass particle in a vial. This recall is a precautionary measure implemented after a customer complaint led to an investigation confirming the contamination. No adverse events related to this recall have been reported to date.
Veklury® is a critical treatment option for COVID-19, indicated for adult and pediatric patients hospitalized with the virus or those with mild to moderate symptoms who are at high risk of severe progression. The presence of glass particles in injectable medications can pose significant health risks. These particles may cause local irritation or swelling at the injection site and, more seriously, can travel through the bloodstream to vital organs. If the glass particles obstruct blood vessels, they can lead to severe medical conditions such as stroke or even death.
The affected product is the lyophilized form of Veklury®, packaged in single-dose clear glass vials. The specific lot under recall is lot #47035CFA, which was distributed across the United States between July 16, 2024, and August 7, 2024. The vials have an expiration date of November 2025. Gilead is taking prompt action by notifying distributors and customers, including pharmacies, through UPS next day air mail. They have also facilitated the return of any remaining vials from this lot.
Healthcare facilities in possession of the recalled Veklury® are instructed to cease its use immediately and return the product as per the instructions provided in Gilead’s notification letter. For questions regarding the recall, Gilead Medical Information is available at 1-866-633-4474, Monday through Friday, from 5 a.m. to 6 p.m. PST, or through their website at www.askgileadmedical.com.
The recall has been conducted with oversight from the U.S. Food and Drug Administration (FDA). Consumers who have used this product and experienced adverse reactions are encouraged to report these incidents to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, mailed, or faxed by downloading the form or calling 1-800-332-1088 to request it. Completed forms can be sent to the address provided or submitted by fax to 1-800-FDA-0178.
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