Par Health Usa, Llc: Dexmedetomidine Hcl In 0.9% Sodium Chloride Injection, 400 Mcg/100 Ml (4mcg/ml)
- Recalling firm
- Par Health USA, LLC
- Product
- Dexmedetomidine HCL in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4mcg/mL), Rx Only, 10x100 mL Single-Dose Vials per carton, Manufactured for: Endo USA, Malvern, PA 19355, Carton: NDC 42023-187-10. Vial NDC: 42023-187-01
- Reason
- Presence of Particulate Matter: the particulate was identified as cellulose or stopper material
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-21
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the U.S.A
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/c8f18683-4e69-4860-b3ab-fbe020f1bf09