FDA Recall of Injectable Covid-19 Medication

The FDA announced an urgent recall for an injectable Covid-19 drug, Veklury (remdesivir). The manufacturer confirmed the presence of glass particles in one lot of the drug. Consumers who receive injections of the drug are at high risk of serious and life-threatening health outcomes. The COVID-19 treatment is typically administered to adults and children with mild to moderate COVID-19 at high risk for illness progression.

All healthcare facilities and staff who administer the medication must closely examine all vials of the drugs in their possession. Patients should ask healthcare providers to closely examine each vial prior to accepting their injection.

As of this notice, the drug’s manufacturer has not announced any reports of adverse events related to the glass particulate matter.

SUMMARY

Date of Recall:

Announced: September 20, 2024

Public Notification: September 23, 2024

Name(s) of Drug:

Veklury (remdesivir)

Company Name:

Gilead Sciences, Inc.

Drug Indication:

Covid-19

Product Description

Veklury® is available by prescription only and is distributed nationwide to medical facilities and pharmacies.  Each glass vial contains 100mg of powdered drug. A healthcare professional must reconstitute and dilute the drug before administration. Once properly prepared, they administer the drug intravenously through an infusion.

Reason for Recall

Gilead Sciences, Inc. received a complaint that there were glass particles in one vial of the drug. Investigators identified and confirmed the particles to be glass. It is unknown how the glass came to be in the vial.

Impacts

Consumers who receive an intravenous injection of the solution are at serious risk of health outcomes related to the glass particulate. The particles may travel throughout the bloodstream and block vessels to vital organs, including the brain, heart, and lungs, leading to stroke or death.  

Lot Information

Healthcare workers: Check your stock carefully to ensure the recalled medication is removed and not administered to your patients. If you have the recalled drug in stock, read below for instructions on disposal.

Consumers: If you believe you have been administered this medication, ask your healthcare provider to verify that you have not received a dose from the recalled stock. Communicate any health changes with your physician immediately.

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

1. Call your doctor right away. Report the use of the recalled medication.
2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
3. Consumers with questions may contact Gilead Medical Information by phone at 1-866-633-4474. They are available Monday through Friday from 5 a.m. to 6 p.m. PST.
4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Medical Facilities

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Gilead Medical Information by phone at 1-866-633-4474. You can then notify them of any recalled batches that have already been administered to patients.
3. Notify affected patients of recalled batches that they have already received.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

1. Examine all inventory and remove stock affected by the recall immediately.
2. Contact Gilead Medical Information by phone at 1-866-633-4474. You can then notify them of any recalled batches that have already been shipped to medical facilities.
3. Notify affected facilities of recalled batches that they have already or will receive.
4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!