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Medicine / D-0814-2026

U.S. Food and Drug AdministrationD-0814-2026

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter…

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

What was recalled

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.

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.