FDA MedWatch – One Lot of Veklury (Remdesivir) for Injection 100 mg/vial by Gilead

TOPIC: One Lot of Veklury (Remdesivir) for Injection 100 mg/vial by Gilead: Recall – Due to the Presence of a Glass Particle

AUDIENCE: Patient, Health Professional, Pneumology

ISSUE: Gilead Sciences is recalling of one lot of Veklury (Remdesivir) for Injection 100 mg/vial because 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.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: 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. The product being recalled is the lyophilized form of Veklury (Remdesivir) for Injection 100 mg/vial.

RECOMMENDATIONS: 

• 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.

• Consumers and healthcare providers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474 or through their website at www.askgileadmedical.com.

• 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 company’s letter.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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