The FDA has listed a Class II recall of pantoprazole sodium 80 mg in 100 mL of 0.9% sodium chloride, the 0.8 mg/mL single-dose infusion bag from Baxter Healthcare Corporation. The reason is deviations from current good manufacturing practice, and the recall is ongoing.
It is the fourth Baxter premixed container listed with a Class II recall dated 9 September, alongside vancomycin, amiodarone and vasopressin. Class II is the middle tier, used where exposure may cause temporary or medically reversible harm. This is a manufacturing quality action rather than a finding about pantoprazole.
The practical consequence is narrow but real. The premixed pantoprazole bag is what gets hung for an upper gastrointestinal bleed at night, when the infusion needs to start before the endoscopy list. If your unit has standardised on it, check the lot list, and confirm that reconstitution from vials is a step the night staff can do without looking it up. Four recalls in one batch from one manufacturer is also a reason to ask what else on the resuscitation trolley comes from a single source.
- Check stock against the recalled pantoprazole presentation and lot numbers.
- Confirm that staff can prepare a pantoprazole infusion from vials without delay.
- This is a manufacturing quality recall, not a safety finding about pantoprazole.
- Three other Baxter premixes carry recalls of the same date - review single-supplier dependence.
- A US recall does not affect Indian supply unless the product was imported.
Why it matters
The premixed bag exists so an infusion can start before the scope, and a shortage is felt at exactly that moment.
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