Class I Recall for COVID-19 Treatment
Just over 100 000 vials of Veklury (remdesivir) for injection are under a Class I recall after a customer found a glass particle in a vial, according to the October 9, 2024, US Food and Drug Administration (FDA) Enforcement Report.
“The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material,” recalling firm Gilead Sciences Inc. stated in a September 20, 2024, announcement. “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.”
The recall affects Veklury for Injection in 100-mg single-dose vials (NDC 61958-2901-2) from lot 47035CFA (Exp. 11/25). The product was manufactured for Gilead Sciences, Foster City, California, and was distributed throughout the United States beginning July 16, 2024.
Gilead Sciences voluntarily initiated the recall on September 19, 2024. On October 3, 2024, the FDA designated the recall Class I. The FDA’s most serious recall classification, a Class I designation warns that use of the affected product could cause serious adverse health consequences or death.
At the time of the company announcement, Gilead had not received any reports of adverse events related to the recall.
Veklury for injection, 100 mg/vial, is indicated for the treatment of COVID-19 in hospitalized patients or those not hospitalized but at high risk for progression to severe COVID-19. It can only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction and the ability to activate the emergency medical system.
