Medicine recalls
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| The United States: Nova-Tech, Inc. issues voluntary nationwide recall of Lactated Ringers 5L Injectable Solution for veterinary use due to potential presence of fiber-like particles |
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The US Food and Drug Administration (FDA) announces that Nova-Tech, Inc. is voluntarily recalling one lot of Lactated Ringers Injection 5000 mL for Animal Use Only (lot number: C2411061) to the end user level. The Lactated Ringers Injection has been found to potentially contain fiber-like visible particles.
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. It is indicated for the correction of electrolyte depletion, metabolic acidosis and dehydration of cattle, calves, horses, sheep and swine.
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 issue was discovered by Nova-Tech during visual inspection for stability testing.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nova-tech-inc-issues-voluntary-nationwide-recall-lactated-ringers-5-l-injectable-solution-veterinary
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Mar 6, 2025
Issued at HKT 16:30
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