Dexmedetomidine Hydrochloride Injection 0.5 mg/mL
Product details
- Dexmedetomidine Hydrochloride Injection 0.5 mg/mL
Company announcement
Cronus Pharma LLC is voluntarily recalling Dexased™ and Dexmedvet™ Dexmedetomidine Hydrochloride Injection 0.5 mg/mL for veterinary use.
The recall is due to the presence of visible particulate matter observed in the solution.
The affected batch numbers are C24041AV1 and C24041AV2. The manufacturing date is November 2024 and the expiration date is October 2026.
Distribution dates ranged from December 2024 to April 4, 2025.
Risk:
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.
Impacted states: Nationwide
Products:
- Dexased™ (Aspen) Dexmedetomidine Hydrochloride Injection 0.5mg/ml
- DexmedVet™ (Cronus Pharma LLC) Dexmedetomidine Hydrochloride Injection 0.5mg/ml
Contact
For more information, call 1-844-227-6687 or email pv@cronuspharmausa.com.