Gilead Sciences announced the voluntary recall of COVID-19 antiviral medication Veklury (remdesivir) after finding the presence of a glass particle in one of the medicine vials.
After receiving a customer complaint, the company investigated the incident and confirmed the presence of the particle, according to a recall notice published on Sept. 20 by the U.S. Food and Drug Administration (FDA). Veklury is used to treat COVID-19. The injections treat adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg or about 3.3 lbs). The patients can be hospitalized or have mild-to-moderate COVID-19 with a high risk for progression to severe disease.
“The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material,” the statement said. “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.”
The recall notice was issued for one lot of Veklury with 100 mg/vial.
“The product being recalled is the lyophilized form of Veklury® (remdesivir) for Injection 100 mg/vial packaged in single dose clear glass vials in powder form. Veklury lot # 47035CFA was distributed nationwide in the United States, beginning 16 July 2024,” the notice said.
According to the notice, California-based Gilead is notifying distributors and customers and is facilitating the return of any remaining vials from the affected lot. Facilities that have vials for the affected lot should stop using them and return them according to the company’s instructions, the notice said.
If patients using the product face any problems, they are advised to consult their health care providers. Adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program.
Injecting Glass Particles
Based on a report by Cytiva Life Sciences, glass ampoules—small sealed glass capsules containing liquid medicines—pose one of the most common causes of occupational injuries among workers administering the injections, such as nurses.In the event of ampoule breakage, glass particles will be transferred to the patient by injection. The particles travel through the blood vessels and can cause side effects such as “pulmonary thrombi, micro-emboli, infusion phlebitis, end-organ granuloma formation, and inflammation,” said the report by Dr. Volker Luibl.
A study published in 2021 said that nurses need more training on properly opening glass ampoules. When standards improve, there is a minimization of the risk of glass particle contamination and an increase in patient safety.
“Contamination of medication contents by glass particles is a common phenomenon following the opening of glass ampoules,” said the International Journal for Quality in Health Care report. “Glass particles may be injected into the body by intramuscular and intravenous administration routes, which have been reported to be dangerous or harmful to the patients.”
The circulating particles may cause pulmonary emboli, infusion phlebitis, granuloma formation, or nodular liver fibrosis, as well as hematoma formation, acute inflammation, and transient nodules.
While plastic containers have been suggested as an alternative, plastic is not compatible with all medications and may cause reactions. “Therefore, ampoule breaking methods remain the primary process in preparing medication injections.”
