Animal IV Product Recalled Due to Potential Presence of Fiber-Like Particles

Injected animals may suffer from blood clots and stroke, potentially resulting in death.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

An intravenous therapy product used in animals has been recalled nationwide in the United States following concerns about the potential presence of particulate matter, according to the U.S. Food and Drug Administration (FDA).

Nebraska-based Nova-Tech Inc. is withdrawing one lot of its Lactated Ringers Injection after determining that the product could potentially be contaminated with “fiber-like visible particles,” the company said in a March 4 recall announcement published by the FDA.

The injected solution is used to rehydrate or maintain hydration in animals. It replaces lost fluids and helps in restoring electrolyte balance. However, using injections containing particulate matter “may result in serious adverse events,” the company warned.

Potential complications 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 recall announcement said.

“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.”

The item comes packaged in 5-liter IV bags with 2 units per case, with lot code #C2411061 and a November 2026 expiration date. It was distributed between Dec. 31, 2024, and Feb. 28, 2025, across the United States.

Nova-Tech identified the issue while visually inspecting the product for stability testing. There has not been any report of adverse events so far.

The company “is notifying its distributors and customers by email and regular mail and is arranging for the return of all recalled products.”

In addition, veterinarians who have the injection in stock should return them to the distributor, according to the announcement.

Some of the likely symptoms of adverse events include paralysis, vomiting, pain, labored breathing, loss of consciousness, a decline in activity level, swelling, fever, and weakness.

“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.”

Consumers with queries regarding the recall can get in touch with the company at 308-381-8841.

The FDA has previously issued recalls of Lactated Ringers Injection, citing contamination risks.

In 2020, California-based ICU Medical Inc. announced a nationwide withdrawal of the injections due to a risk of the presence of iron oxide. The item was for use in both animals and humans.

ICU Medical also recalled the injection earlier in 2019 “due to the presence of particulate matter.” The item was aimed for veterinary use.