Elevated risk U.S. Food and Drug Administration

Nova-Tech Lactate Ringers Injection 5000 mL recall: Potential presence of fiber-like particles

Recall published 1+ years ago

Potential presence of fiber-like particles.

Nova-Tech Pet food & treats — recalled pet food & treatsNova-Tech Pet food & treats — recalled pet food & treats (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

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
March 4, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Nova-Tech
Product type
Pet food & treats
Distribution
Nationwide
UPC codes
365207803803

Products covered by this recall

Lactate Ringers Injection 5000 mL

What the company announced

FOR IMMEDIATE RELEASE – March 4th, 2025 – Grand Island, Nebraska, Nova-Tech, Inc. is voluntarily recalling one (1) lot of Lactated Ringers Injection for Animal Use Only to the end user level. The Lactated Ringers Injection has been found to potentially contain fiber- like visible particles.

Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications related to injection of particles include inflammation of a vein, granuloma, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events, including death. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.

Some possible signs and symptoms of an adverse event include pain, weakness, swelling, paralysis, fever, labored or fast breathing, vomiting, decreased activity level, vocalization, or loss of consciousness. If you observe any of these or any other concerning signs in an animal that may have been administered this product, please contact a veterinarian as soon as possible.

To date, Nova-Tech, Inc has not received any reports of adverse events related to this recall. The product was distributed between December 31st, 2024 and February 28th, 2025.

The issue was discovered by Nova-Tech during visual inspection for stability testing.

The product is used as an injectable solution as directed by a veterinarian and is packaged in 5-liter IV bags with 2 units per case (unit UPC 365207803803). The affected Lactated Ringers Injection 5- Liter is lot # C2411061, expiration date NOV 2026. The product can be identified by item code 18- 803-80, NDC # 65207-803-80. Lactated Ringers Injection was distributed nationwide to wholesale distributors.

Nova-Tech, Inc is notifying its distributors and customers by email and regular mail and is arranging for the return of all recalled products. Veterinarians that have affected Lactated Ringers Injection 5-Liter lot # C2411061 which is being recalled should return to the distributor.

Consumers with questions regarding this recall can contact Nova-Tech, Inc. by phone 308-381- 8841 or e-mail [email protected] Monday to Friday from 8:00 AM – 4:00 PM central time. Consumers should contact their veterinarian 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 online at http://www.FDA.gov/reportanimalAE .

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

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

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 365207803803

Lot or batch code

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

  • C2411061

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • NOV 2026

NDC number

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

  • 65207-803-80

Model or item number

On the rating label, the box or the instruction sheet.

  • 18- 803-80

Package size

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

  • 5000 mL
  • 5 liter
  • 5 L

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 Sterility

Nova-Tech — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Nova-Tech, Inc. — Consumers: Nova-Tech, Inc., 308-381- 8841, [email protected] — Media: Teresa Grabowski, 308-381-8841

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 Nova-Tech pet food & treats recalled?

Potential presence of fiber-like particles. Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 365207803803; lot code C2411061; best-by date NOV 2026; model number 18- 803-80. 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 using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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