The FDA has listed a Class II recall of Nexterone (amiodarone hydrochloride) 360 mg in 200 mL, the 1.8 mg/mL premixed single-dose container, from Baxter Healthcare Corporation. The stated reason is deviations from current good manufacturing practice, and the recall status is ongoing.
Class II is the middle tier: the FDA uses it where exposure may cause temporary or medically reversible harm and serious harm is unlikely. It is a manufacturing quality action, not a finding about amiodarone itself. The premixed bag is the convenient form for a crash trolley or a coronary care unit precisely because it needs no dilution, which is also why a shortage of it is felt at the bedside rather than in the pharmacy.
The practical step is a stock check against the affected presentation and lot list, and confirming that staff who normally reach for a premixed bag know how to prepare amiodarone from ampoules if they have to.
- Check crash trolley and coronary care stock against the recalled presentation and lot numbers.
- Confirm staff can prepare amiodarone from ampoules if premixed bags are unavailable.
- This is a manufacturing quality recall, not a safety signal about the drug.
- Indian supply is unaffected by a US recall unless the product was imported.
- Class II means temporary or reversible harm is possible and serious harm unlikely.
Why it matters
Premixed emergency drugs are stocked because nobody wants to be diluting at a cardiac arrest; losing the bag changes what happens in the room.
Don't overread it
A manufacturing recall says nothing about the safety or efficacy of amiodarone as a drug.
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