The FDA enforcement report lists a Class II recall of Myxredlin, regular human insulin 100 units in 100 mL of 0.9% sodium chloride (1 unit/mL), made by Baxter Healthcare. The stated reason is deviations from current good manufacturing practice. The recall is listed as ongoing and is dated 9 September 2026.
Class II means use may cause temporary or medically reversible harm, or that serious harm is remote. The report does not describe a specific defect or any reported harm.
This product is a ready-to-use bag for intravenous insulin infusions in hospital. Its availability in India is not established here; units elsewhere using it should check affected lots with their pharmacy.
- Hospital pharmacies using premixed IV insulin bags should check lot numbers against the FDA recall notice.
- Where bags are withdrawn, revert to locally prepared insulin infusions using the unit's standard concentration and protocol.
- Check capillary glucose closely after any change in infusion preparation.
- The recall concerns manufacturing practice, not a demonstrated problem with insulin itself.
Why it matters
A change in infusion source is a known moment for insulin dosing errors on the ward.
Don't overread it
A Class II manufacturing recall is administrative; it does not indicate a safety finding with intravenous insulin.
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