Gilead Recalls COVID-19 Drug Veklury For Injection
(RTTNews) - Foster City, California-based Gilead Sciences, Inc. is recalling one lot of Veklury (remdesivir) for Injection 100 mg/vial for treating COVID-19, to the consumer level, due to the presence of a glass particle, according to the U.S. Food and Drug Administration.
The recall involves Veklury (remdesivir 100mg for injection) with NDC 61958-2901-02, lot # 47035CFA and Expiration Date 11/2025. The drug was distributed to wholesalers nationwide in the United States from 07/16/2024 to 08/07/2024.
The product being recalled is the lyophilized form of Veklury for Injection 100 mg/vial packaged in single dose clear glass vials in powder form.
Veklury (remdesivir) for Injection 100 mg/vial is indicated for the treatment of COVID-19 in adults and pediatric patients from birth to less than 18 years of age weighing at least 1.5 kg.
The injection is indicated for patients 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 recall was initiated after the company received a customer complaint. During an investigation, the firm confirmed the presence of a glass particle in the vial.
The administration of an injectable product containing glass particles could 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. This could cause stroke and even lead to death.
However, Gilead has not received any reports of adverse events related to the recall so far.
The company urged facilities that have recalled Veklury to stop using the affected lot and return the product vials per the instructions.
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