The FDA enforcement report dated 9 September lists a Class II recall by Baxter Healthcare of Nexterone (amiodarone hydrochloride) 360 mg/200 mL (1.8 mg/mL) in GALAXY single-dose containers, for deviation from current good manufacturing practice. It is ongoing. The same report lists Class II recalls of Baxter premixed vancomycin and vasopressin for the same reason.
The notice describes no specific defect or harm. Nexterone is formulated to avoid the polysorbate and benzyl alcohol in conventional amiodarone ampoules, which are linked to hypotension on rapid infusion and require non-PVC giving sets. Switching to ampoule-based infusions therefore changes preparation, not just supply. The recall is a US action; Indian availability is not stated.
- Check with pharmacy whether affected Nexterone lots are held
- If switching to ampoules, dilute in 5% glucose and follow local concentration limits
- Use a central line for concentrations above 2 mg/mL where possible
- Monitor blood pressure closely during loading with conventional formulations
Why it matters
The substitute formulation carries different infusion risks, so the recall changes how amiodarone is given.
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A CGMP recall is a manufacturing finding, not evidence that patients were harmed.
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