Recall archive / FDA company announcement
Dexased™ and Dexmedvet™: Dexmedetomidine Hydrochloride Injection 0.5 mg/mL — FDA announcement Apr 24, 2025
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Apr 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Dexmedetomidine Hydrochloride Injection 0.5 mg/mL
- Reason
- Presence of particulate matter
- Classification
- Not supplied
- Recalling firm
- Cronus Pharma LLC
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 7680a063cef700fd
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | East Brunswick, NJ, April 23, 2025 - 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) and Dexmedvet™ (Cronus Pharma LLC). 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.; Dexased™: Dexmedetomidine Hydrochloride Injection 0.5mg/ml (Aspen), NDC No: 46066-088-13, Batch No: C24041AV1, Mfg. Date: Nov 2024, Exp. Date: Oct 2026.Distribution Dates: December 2024 to 04-April-2025; DexmedVet™: Dexmedetomidine Hydrochloride Injection 0.5mg/ml (Cronus Pharma LLC), NDC No: 69043-038-10, Batch No: C24041AV2, Mfg. Date: Nov 2024, Exp. Date: Oct 2026.Distribution Dates: March 2025 to 04-April-2025; A photo of the vial of each lot number that is part of the recall can be found at the end of this press release. The lot number (LOT) and expiry date (EXP) are located on the bottom right portion of the bottle label. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Apr 24, 2025
- Company announcement date
- Apr 23, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.