Gilead Sciences Recalls Remdesivir Lots Over Glass Particulates

Gilead Sciences has recalled two lots of its blockbuster COVID-19 antiviral Veklury (remdesivir) for possible contamination with glass particulates.

Approximately 55,000 vials are affected by the recall, lots 2141001-1A and 2141002-1A which were distributed in the U.S. beginning in October and have expiration dates of January 2024.

“An investigation is underway to determine the cause of the issue in the manufacture of these two specific lots,” a Gilead spokesperson told FDAnews yesterday, noting that the recall doesn’t “affect any other lots of Veklury distributed in the U.S., distributed in any other country, generic remdesivir available through our voluntary licensing partners or any other Gilead product.”

Gilead previously estimated that more than half of all hospitalized U.S. COVID-19 patients are treated with Veklury.

The company said it has not received any reports of adverse events linked to the recalled lots but that hospitals should stop using them immediately, noting that if the particulates from the injectable drug were to reach blood vessels they could travel to the heart, lungs or brain, “which can cause stroke and even lead to death.”  

In September, Gilead reported that Veklury cut hospitalizations and death by 87 percent in patients with newly diagnosed COVID-19 in a 562-participant phase 3 study. A previous study by the World Health Organization last year suggested the drug offered no meaningful benefit for COVID-19 patients (DID, Sept. 24).

Veklury, which earned more than $2.8 billion in 2020, may soon face competition from COVID-19 antivirals from Merck’s molnupiravir and Pfizer’s Paxlovid (PF-07321332; ritonavir). ― Jason Scott