The FDA has listed a Class II recall of vancomycin injection 1 g in 200 mL of 0.9% sodium chloride, the 5 mg/mL premixed single-dose container from Baxter Healthcare Corporation. The reason given is deviations from current good manufacturing practice, and the recall is ongoing.
Class II is the FDA's middle tier, used where exposure may cause temporary or medically reversible harm and serious harm is unlikely. It is a manufacturing quality action rather than a finding about vancomycin. Notably, a Class II recall of a premixed amiodarone container from the same manufacturer was listed on the same date.
The operational consequence is supply, not safety. Premixed vancomycin exists so that a ward can hang a bag without a pharmacy step, and units that have moved to premixed presentations often no longer stock the vials or keep the reconstitution competency current. Check the lot list against your stock, and confirm the fallback is real rather than nominal.
- Check ward and pharmacy stock against the recalled presentation and lot numbers.
- Confirm that staff can still reconstitute vancomycin from vials if premixed bags run short.
- This is a manufacturing quality recall, not a safety signal about vancomycin.
- A premixed amiodarone container from the same firm carries a recall of the same date.
- A US recall does not affect Indian supply unless the product was imported.
Why it matters
Units that switched to premixed bags often let the reconstitution skill lapse, and a recall is when that becomes visible.
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