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Safety Report: Gilead Veklury (remdesivir) for Injection - recalled due to presence of Glass Particle, USA

1 day ago •source fda.gov

Recall notice

Gilead Veklury (remdesivir) for Injection - recalled due to presence of Glass Particle photo #1

United States

Gilead Sciences, Inc. issued a voluntary recall of one lot of Veklury® (remdesivir) for Injection to the consumer level. The product was distributed nationwide in the United States, beginning 16 July 2024

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.

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
- 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 with Lot # 47035CFA. NDC: 61958-2901-02, Expiration Date: 11/2025.

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.

In case you experienced harm from extraneous materials, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Gilead Sciences, Inc.
Brand name: Gilead
Product recalled: Veklury (remdesivir) for Injection
Reason of the recall: Due to Presence of Glass Particle
FDA Recall date: September 23, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-one-lot-veklury-remdesivir-injection-100-mgvial-due

#drugs #recall #us

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