Elevated risk U.S. Food and Drug Administration

Gilead Veklury for Injection recall: Due to Presence of Glass Particle

Recall published 2+ years ago

Due to Presence of Glass Particle

Gilead Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — glass

The company found glass in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

What the notice says: Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material.

Why it matters: Pieces of glass may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: glass is usually visible on an X-ray, and a swallowed shard is one of the cases where imaging is worth doing.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
September 20, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Gilead
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Veklury (remdesivir) for Injection

What the company announced

FOR IMMEDIATE RELEASE - Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation.

Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material. 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.

Veklury® (remdesivir) for Injection 100 mg/vial is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are:

Hospitalized, or

Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death

Veklury® (remdesivir) for Injection 100 mg/vial may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.

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. NDC, lot, expiration date and distribution dates can be found in the table below.

  • Product Description: Veklury® (remdesivir 100mg for injection) · NDC: 61958-2901-02 · Lot #: 47035CFA · Expiration Date: Exp. Date 11/2025 · Distribution Date to Wholesalers: 07/16/2024 to 08/07/2024

Gilead is notifying its distributors and customers via UPS next day air mail to pharmacies and is facilitating the return of any remaining vials from the affected lot. Facilities that have Veklury® (remdesivir) for Injection 100 mg/vial which is being recalled should stop using the affected lot and return the product vials per the instructions in the letter.

Consumers and healthcare providers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474 Monday to Friday 5am - 6pm PST or through their website at www.askgileadmedical.com . 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Note regarding forward-looking statements

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 47035CFA

NDC number

On the carton and again on the bottle or blister label.

  • 61958-2901-02

Package size

Match the net weight or the piece count on the front of the pack.

  • 100 mg
  • 1.5 kg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Glass pieces

Gilead — The company found glass in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  3. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  4. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: Facilities that have Veklury® (remdesivir) for Injection 100 mg/vial which is being recalled should stop using the affected lot and return the product vials per the instructions in the letter.

Company contact: Gilead Sciences, Inc. — Consumers: Gilead Medical Information, 1-866-633-4474

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Gilead prescription & otc drugs recalled?

Due to Presence of Glass Particle Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 47035CFA. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

The notice says: Facilities that have Veklury® (remdesivir) for Injection 100 mg/vial which is being recalled should stop using the affected lot and return the product vials per the instructions in the letter.

Where was the recalled product sold?

It was distributed nationwide.

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