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