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Medicine / D-0810-2026

U.S. Food and Drug AdministrationD-0810-2026

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…

Class II Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

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.

Recalling firm

Baxter Healthcare Corporation

Reason for recall

CGMP Deviations

Where it went

US Nationwide; Puerto Rico; and Chile.

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.