The FDA enforcement report dated 9 September lists a Class II recall by Baxter Healthcare of vasopressin in 0.9% sodium chloride, 20 units per 100 mL (0.2 units/mL), in 100 mL single-dose containers. The stated reason is deviation from current good manufacturing practice. The recall is ongoing.
Class II means temporary or reversible harm is possible and serious harm is remote. The report gives no specific defect or patient injury. The practical impact is supply: units using premixed vasopressin may need to return to pharmacy- or bedside-prepared infusions, with the usual risk of concentration errors in a high-alert drug. A sister Class II recall of Baxter premixed vancomycin was listed on the same day. The recall is a US action; Indian availability is not stated.
- Ask pharmacy whether affected vasopressin lots are in ED or ICU stock
- If preparing infusions locally, standardise one concentration and label it clearly
- Double-check pump programming for any change in concentration
- Continue using vasopressin as indicated; the recall is not a safety signal about the drug
Why it matters
Changing from a premixed bag to a locally mixed vasoactive infusion is when dosing errors happen.
Don't overread it
A CGMP recall reflects manufacturing findings, not a known risk from vasopressin itself.
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