Veterinary Injection Recall Due to Particulate Matter by Cronus Pharma

Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL due to particulates matter in the product. Two lots of the product, Dexased (Aspen Veterinary Resources, LTD) & DexmedVet (Cronus Pharma LLC) are being recalled. The products are manufactured in India.

The Injection drug product is being recalled due to the presence of visible particulate matter (crystal-like particles, white floating matter, or precipitates) observed in the solution. Dexmedetomidine Hydrochloride Injection is indicated for use as a sedative and analgesic in dogs and cats. As per the Company announcement, Administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications include inflammation, granuloma, fibrosis, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events, including death.

Recall Announcement – Cronus Pharma LLC (April 2025)