Medicine recalls
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| The United States: Cronus Pharma LLC initiating voluntary recall for (Dexased™ -Aspen and Dexmedvet™ -Cronus Pharma LLC) of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL for veterinary use due to presence of particulate matter |
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The US Food and Drug Administration (FDA) announces that Cronus Pharma LLC, on behalf of Cronus Pharma Specialties, Hyderabad, India is issuing a voluntary recall involving one batch comprising two distinct lots: Dexased™ (Aspen) (lot number: C24041AV1) and Dexmedvet™ (Cronus Pharma LLC) (lot number: C24041AV2).
Both products contain Dexmedetomidine Hydrochloride Injection 0.5 mg/mL, which is a prescription product in the United States used as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. This product is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.
The recall is being conducted as a precautionary measure due to the presence of visible particulate matter (described as crystal-like particles, white floating matter, or precipitates) observed in the solution. 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. The overall risk depends on factors such as the route of injection, the composition of the particulate matter, and patient comorbidities.
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 any of these or any other concerning signs are observed in an animal that may have been administered this product, please contact a veterinarian as soon as possible.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cronus-pharma-llc-initiating-voluntary-recall-dexasedtm-aspen-and-dexmedvettm-cronus-pharma-llc
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Apr 25, 2025
Issued at HKT 17:15
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