|
|
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
|
|
|
TOPIC: Two Lots of Veklury (Remdesivir) by Gilead: Recall Due to Presence of Glass Particulates
AUDIENCE: Patient, Health Professional, Risk Manager, Laboratory
ISSUE: Gilead is recalling two lots of Veklury (remdesivir 100 mg for injection) due to the presence of glass particulates.
Risk Statement: The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel 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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Veklury is indicated for the treatment of adults and pediatric patients ≥ 12 years old and weighing ≥ 40 kg requiring hospitalization for COVID-19.
RECOMMENDATIONS:
- Hospitals that have Veklury which is being recalled should stop using the affected lots and return the product vials per the instructions.
- Consumers with questions regarding this recall can contact Gilead Medical Information.
- Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
|
|
|
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
-
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
|
|
|
|
