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.