# Major Recall Alert: Dexmedetomidine Hydrochloride Injection 0.5 mg/mL Recalled Due to Presence of Particulate Matter
Cronus Pharma LLC has issued an urgent voluntary recall for Dexased™ (Aspen) and Dexmedvet™ (Cronus Pharma LLC), both of which contain Dexmedetomidine Hydrochloride Injection 0.5 mg/mL. This prescription medication, used as a sedative and analgesic for dogs and cats, is being recalled due to the presence of visible particulate matter in certain batches. Pet owners and veterinarians, here’s everything you need to know to keep your furry friends safe.
## Why This Recall is Important
Administering any injectable product contaminated with particulate matter poses serious health risks. Crystal-like particles, floating white matter, or precipitates were observed during visual inspections of the affected lots. These particles can cause severe adverse effects, including:
- **Inflammation or granulomas** at the injection site,
- **Fibrosis** (thickened or scar-like tissue),
- **Blood vessel blockages** in vital organs such as the heart, lungs, or brain, potentially leading to **strokes**, **blood clots**, or even **death**.
Veterinary professionals and pet owners should remain vigilant, as symptoms of an adverse reaction may include:
- Pain or swelling at the injection site,
- Weakness, paralysis, or decreased activity levels,
- Labored or fast breathing,
- Vomiting, fever, or vocalization,
- In extreme cases, loss of consciousness.
If any of these signs occur after administering this drug, contact a veterinarian immediately.
## Details of the Recall
This voluntary recall issued by Cronus Pharma LLC and Cronus Pharma Specialties (Hyderabad, India) affects the following products:
- **Brand Names**: Dexased™ (Aspen) and Dexmedvet™ (Cronus Pharma LLC)
- **Product**: Dexmedetomidine Hydrochloride Injection 0.5 mg/mL
- **Affected Lot Numbers**:
- C24041AV1
- C24041AV2
- **Reason for Recall**: Contamination with visible particulate matter (crystal-like particles).
The recall is being coordinated with the knowledge of the U.S. Food and Drug Administration (FDA).
### Risks of Affected Product
While Dexmedetomidine Hydrochloride Injection is widely utilized for its sedative and analgesic properties to facilitate clinical exams, minor surgeries, and preanesthetic procedures, the presence of particulate matter presents significant risks during injection. Effects depend on factors such as the injection route, the type of contaminating particles, and the overall health of the animal.
### Cronus Pharma LLC’s Statement
Cronus Pharma LLC emphasizes its strong commitment to ensuring the health of pets. The company has implemented high-quality standards in manufacturing and is working proactively to remove affected products from distribution channels.
## What You Should Do
Pet owners, veterinarians, and distributors who purchased Dexased™ and Dexmedvet™ should immediately take the following actions:
- **Stop Using the Product**: Cease administration of products from the recalled lots (C24041AV1 and C24041AV2).
- **Contact Your Supplier**: Refer to your recall notification letter for specific product return instructions or contact the point of purchase for details on returns.
- **Report Any Adverse Reactions**: Notify the FDA of any side effects or quality concerns at 1-888-FDA-VETS or online at [FDA.gov/reportanimalae](http://www.fda.gov/reportanimalae).
For additional information or technical inquiries about this recall, consumers can contact Cronus Pharma LLC directly by:
- **Phone**: 1-844-227-6687 (Monday-Friday, 9 a.m. – 5 p.m. CDT)
- **Email**: pv@cronuspharmausa.com
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### Stay Informed
For more details on this recall, visit the FDA’s official recall notice here: [Cronus Pharma LLC Recall](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cronus-pharma-llc-initiating-voluntary-recall-dexasedtm-aspen-and-dexmedvettm-cronus-pharma-llc).
Protect your pets and ensure their safety by acting now!