The FDA enforcement report lists a Class II recall of Nexterone, amiodarone 360 mg in 200 mL (1.8 mg/mL) in single-dose GALAXY containers, made by Baxter Healthcare. The stated reason is deviations from current good manufacturing practice; the recall is ongoing and dated 9 September 2026.
Class II means use may cause temporary or medically reversible harm, or that serious harm is remote. No defect or harm is described in the report.
The premixed bag avoids the need to prepare amiodarone in glucose and use non-PVC equipment for long infusions. Availability in India is not established here; hospitals using it should check lots with pharmacy.
- Check premixed amiodarone stock against the FDA recall list.
- If substituting a locally prepared infusion, dilute in 5% glucose and follow the product's container and filter guidance.
- Use a central line for prolonged or concentrated amiodarone infusions where possible.
- The recall concerns manufacturing practice, not amiodarone's efficacy or safety profile.
Why it matters
Switching from a premixed to a prepared amiodarone infusion brings dilution and line-compatibility errors.
Don't overread it
A Class II manufacturing recall is administrative; it is not a new safety finding for amiodarone.
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