A voluntary recall of a prescription sedative and analgesic for companion animals has been issued by Cronus Pharma. One lot each for 2 products containing dexmedetomidine hydrochloride injection 0.5 mg\/mL (Dexased, Aspen; and Dexmedvet, Cronus Pharma) are recalled as a precautionary measure because of the presence of visible particulate matter.<\/p>\n
\u201cThe health and well-being of animals is the foremost priority at Cronus Pharma. We place the utmost emphasis on product quality at every step in the manufacturing and supply chain process,\u201d the company noted in a news release.1<\/p>\n
The recalled dexmedetomidine hydrochloride injection products are used for feline and canine patients to help facilitate clinical examinations and procedures as well as minor surgical and dental procedures. Additionally, dexmedetomidine hydrochloride injection is indicated for use in dogs and cats as a preanesthetic to general anesthesia, according to the FDA.<\/p>\n
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Particulate matter was observed as crystal-like particles or \u201cwhite stuff floating\u201d during visual inspection of control samples for Dexased and Dexmedvet, according to the FDA. Identifying information for the recalled lots are as follows1:<\/p>\n
Pet owners who have received recalled lots of the affected dexmedetomidine hydrochloride injection products should be advised to stop using them. 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.1<\/p>\n
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, according to the FDA. If these or any other concerning signs are observed in an animal that may have been administered this recalled product, a veterinarian should be contacted as soon as possible. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA at 1-888-FDA-VETS or online at\u00a0www.FDA.gov\/reportanimalae<\/a>.<\/p>\n Cronus Pharma\u2014a division of Cronus Pharma Specialties in Hyderabad, India\u2014is working with distribution partners to help ensure that unused product is no longer being distributed or with customers. Cronus Pharma is also notifying its distributors and customers directly and are arranging for the return of the recalled product.1<\/p>\n Pet owners in possession of the affected products with recalled lots should refer to the recall notification with instructions for returns or contact their point of purchase for details. Pet owners with technical questions regarding the recall should call 1-844-227-6687 and send an email to\u00a0pv@cronuspharmausa.com.1<\/p>\n Reference<\/strong><\/p>\n