Glass has been detected in the two lots of Veklury, which is used to treat patients who are hospitalized with COVID-19.
Gilead Sciences is voluntarily recalling two lots of Veklury (remdesivir 100 mg) for injection because of the presence of glass.
The two lots affected are 2141001-1A and 2141002-1A with an expiration date of January 2024 and NDC 61958-2901-02. They were distributed between Oct. 25, 2021, and Nov. 2, 2021.
To date, Gilead Sciences has not received any reports of adverse events related to this recall.
Veklury is used to treat patients 12 years of age and older who require hospitalization for COVID-19. The lyophilized form of Veklury is distributed in single dose clear glass vials in powder form and reconstituted at the site of use.
More than half of patients hospitalized with COVID-19 in the United States are treated with Veklury. The therapy is approved or authorized for temporary use in about 50 countries worldwide, according to Gilead.
Veklury is a nucleotide analog that has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19. It directly inhibits viral replication of SARs-CoV-2 by targeting viral RNA polymerase.
Laboratory findings suggest that Veklury will continue to be active against current in the SARS-CoV-2 virus, according to Gilead. All known variants show mutations at different locations in the SARS-CoV-2 spike protein on the outer surface of the virus.