FDA Class II recall: premixed vancomycin 1 g Galaxy bags

The FDA lists a Class II recall, dated 9 September and ongoing, of Baxter's vancomycin injection 1 g in 200 mL sodium chloride (5 mg/mL) in Galaxy single-dose containers. The stated reason is deviation from current good manufacturing practice.

Class II means use may cause temporary or medically reversible harm, or that serious harm is remote. The notice does not describe a specific defect such as contamination or wrong strength. The recall concerns this premixed product only; vancomycin vials reconstituted on the ward are not affected. Whether this product is distributed in India is not established here.

For pharmacy and prescribers the practical steps are to check lots against the recall, and to make sure any substitution to reconstituted vancomycin keeps the same dose, concentration and infusion rate.

• Ask pharmacy to check Baxter premixed vancomycin 1 g/200 mL Galaxy bags against the recall.
• The recall reason is a manufacturing-practice deviation, not a reported clinical harm.
• When switching to reconstituted vancomycin, keep dose, concentration and infusion rate unchanged.
• Continue level-guided dosing; the recall does not change monitoring.

Why it matters

Supply substitutions are a common point for dosing and infusion-rate errors with vancomycin.

Don't overread it

A Class II recall for manufacturing deviations is not a finding that the product harmed patients.

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