Baxter Healthcare Corporation: Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride Injection, 400 Mcg Per

Recalling firm
Baxter Healthcare Corporation
Product
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
Reason
CGMP Deviations
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-08-06
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide; Puerto Rico; and Chile.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/98008738-4d8e-49a6-ac8f-fc3ef6211dc7