Cronus Pharma LLC has issued a voluntary recall for two products containing Dexmedetomidine Hydrochloride Injection 0.5 mg/mL, used as a sedative and analgesic in dogs and cats. The affected products are Dexased (Aspen) and DexmedVet (Cronus Pharma LLC), with one batch comprising two lot numbers. The recall is due to the presence of visible particulate matter, described as crystal-like particles, observed in the solution.
The lot numbers being recalled include Dexased (Aspen), Batch No: C24041AV1, with distribution dates from December 2024 to April 4, 2025, and DexmedVet (Cronus Pharma LLC), Batch No: C24041AV2, distributed between March 2025 and April 4, 2025. The product, used for clinical and minor surgical procedures as well as a preanesthetic, was manufactured in November 2024 and has an expiry date of October 2026.
Cronus Pharma LLC advises customers who have received the affected lots to stop using the products and follow the instructions in their recall letter for returning the products. They are collaborating with distributor partners to ensure the recalled products are no longer in circulation.
The presence of particulate matter in injectable products could lead to complications such as inflammation, granuloma, fibrosis, and blockage of blood vessels, possibly causing stroke or other serious effects. Symptoms of adverse events in treated animals might include pain, weakness, paralysis, fever, or loss of consciousness, among others.
For technical inquiries regarding the recall, consumers can contact Cronus Pharma LLC at 1-844-227-6687 or via email. Adverse reactions or quality issues can also be reported to the FDA. According to Cronus Pharma LLC, "The health and well-being of animals is the foremost priority... We place the utmost emphasis on product quality at every step in the manufacturing and supply chain process."
This recall has been announced in coordination with the Food and Drug Administration.
