The FDA enforcement report lists a Class II recall of Myxredlin (insulin human in 0.9% sodium chloride, 100 units/100 mL) from Baxter Healthcare, dated 9 September 2026. The stated reason is deviation from current good manufacturing practice. The recall is ongoing.
Class II means use of the product may cause temporary or medically reversible harm, or that serious harm is unlikely. The report does not describe a specific defect or any adverse events.
Myxredlin is a US hospital product used for intravenous insulin infusions. Its availability in India is not established from this record, and no CDSCO action is reported. The relevance for Indian hospitals is indirect: check whether any premixed insulin infusion product in use is affected, and confirm infusion protocols can run on locally prepared insulin if supply is interrupted.
- Check pharmacy stock for Myxredlin and the affected lots if your hospital sources US products
- Confirm your intravenous insulin protocol can use locally prepared infusions
- Report any unexpected glycaemic response during infusion to pharmacovigilance
- Watch for supply updates from the manufacturer
Why it matters
A manufacturing recall on an infusion insulin can disrupt hospital hyperglycaemia and DKA protocols at short notice.
Don't overread it
A Class II recall for manufacturing deviations is not evidence that patients have been harmed.
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