COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Animal & Veterinary
- Reason for Announcement:
-
Recall Reason Description
Potential presence of fiber-like particles.
- Company Name:
- Nova-Tech, Inc.
- Brand Name:
- Product Description:
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Product Description
Lactate Ringers Injection 5000 mL
Company Announcement
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 contact@novatech-inc.com 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.
