A COVID Medication Has Been Recalled Nationwide

Notifications are being sent out to medical clinics and pharmacies, but it’s a swift-moving situation consumers may want to be aware of, too.

Covid-19 differs from other viruses due to its prevalence year-round, and this summer it was often travelers who found themselves infected. The early weeks of September saw infection rates trending downward ever so slightly, according to national data; but as fall takes us indoors and back to school, it’s possible patients could still see themselves requiring treatment.

On Monday, September 23, 2024, the US Food and Drug Administration announced a nationwide recall on remdesivir, which goes by the brand name Veklury. One hundred milligram (100 mg) vials of Veklury have been recalled after its maker, the Silicon Valley-based pharmaceutical company Gilead Sciences, Inc., received a report that a small shard of glass had been found inside a vial—as they say: “Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company’s investigation.” It’s not clear whether the foreign matter was found before or after the product from that vial was administered to any patients.

The recall announcement states the drug is indicated for the treatment of COVID-19 in adults and pediatric patients under 18 years old with a weight of at least 1.5 kilograms who are hospitalized, or who are “not hospitalized but have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.”

As such, the announcement includes the following 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.”

Details on the recalled drug are the following: Veklury lot #47035CFA in lyophilized (freeze-dried) powder form, which was distributed nationwide in the United States, beginning July 16, 2024.

Veklury is to be administered strictly in a healthcare setting. The recall was initiated on Friday, September 20, 2024 and published by the FDA on Monday, September 23, 2024. The announcement states that the manufacturer “is notifying its distributors and customers via UPS next day air mail to pharmacies and is facilitating the return of any remaining vials from the affected lot.” The FDA alert adds: “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.”

The FDA says any complications can be reported to the FDA MedWatch program that tracks quality issues and serious reactions from food, drugs, devices, cosmetics, and other products. It is also advisable to alert your healthcare provider for any suspicion of complication from this drug or any others.

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