QuVa Pharma, Inc. is voluntarily recalling approximately 1,994 bags of Oxytocin 30 Units/500 mL (0.06 Units/mL) added to Sodium Chloride injection for IV use. The recall was issued because the drug was formulated using 0.45% Sodium Chloride instead of the intended 0.9% Sodium Chloride. This is a compounded product intended for institutional or office use only and no injuries have been reported to date.
The use of an incorrect sodium chloride concentration in an IV formulation can lead to electrolyte imbalances in patients. Because oxytocin is a high-alert medication used in clinical settings, receiving the wrong formulation poses a potential risk to patient safety.
Compounded Product for Institutional or Office Use Only; Not for Resale. Added to 0.45% Sodium Chloride instead of 0.9% Sodium Chloride.
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Sources: FDA iRES · Raw API Response
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