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Regulatory · 04 of 06

FDA Class II recall: Baxter Myxredlin insulin infusion

Hospitals using premixed Myxredlin should check stock against the FDA recall listing and keep a compounded infusion protocol ready.

FDA's 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 and listed as ongoing. The stated reason is deviations from current good manufacturing practice.

A Class II recall means use may cause temporary or reversible harm, or that serious harm is remote. The record gives no report of patient injury and does not name affected lots.

This is a premixed intravenous insulin used on wards and in intensive care. Pharmacy teams should check stock against the FDA listing. Myxredlin is a US product; its availability in India is not stated in the record.

  • Ask pharmacy to check Myxredlin stock against the FDA enforcement listing.
  • Have a locally prepared insulin infusion protocol ready if stock is withdrawn.
  • Report any unexpected glucose response on infusion to pharmacovigilance.

Why it matters

Premixed IV insulin supply affects ward and ICU glucose protocols directly.

Don't overread it

A manufacturing-practice recall is not a report of patient harm.

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