Foster City, California-based Gilead Sciences, Inc. is conducting a consumer-level recall of one lot of Veklury (remdesivir) for Injection 100 mg/vial, used for treating COVID-19, due to the presence of a glass particle. This information has been confirmed by the U.S. Food and Drug Administration.
The recall pertains to Veklury (remdesivir 100 mg for injection) bearing NDC 61958-2901-02, lot # 47035CFA, with an expiration date of November 2025. The affected drug was distributed to wholesalers across the United States between July 16, 2024, and August 7, 2024.
The product in question is the lyophilized (powder) form of Veklury for Injection 100 mg/vial, packaged in single-dose, clear glass vials.
Veklury (remdesivir) for Injection 100 mg/vial is prescribed for the treatment of COVID-19 in both adults and pediatric patients from birth to under 18 years of age, weighing at least 1.5 kg. This medication is intended for patients who are either hospitalized or have mild-to-moderate COVID-19 but are at high risk of developing severe COVID-19, which includes the potential for hospitalization or death.
The recall was initiated following a customer complaint. During the subsequent investigation, the presence of a glass particle in the vial was confirmed.
Administering an injectable product containing glass particles could lead to local irritation or swelling due to the foreign material. Glass particulates could potentially travel through blood vessels to various organs, potentially causing blockages in the heart, lungs, or brain, leading to serious conditions such as stroke or even death.
As of now, Gilead has not received any reports of adverse events related to this recall.
Gilead has advised facilities in possession of the recalled Veklury lot to cease usage immediately and return the product vials as per the provided instructions.
