Otsuka ICU Medical Recalls Saline Bags Mislabeled as Potassium Chloride
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Austin, Texas – – September 19, 2026 -- Otsuka ICU Medical LLC has issued a voluntary user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, after discovering that bags labeled as saline may actually contain highly concentrated Potassium Chloride Injection.
Mislabeled overwrap conceals lethal potassium concentrate inside saline packaging
The affected lot, NDC 0990-7984-23, Lot 1042188, carries external labeling identifying it as 0.9% Sodium Chloride Injection, USP. Internally, however, the overwrap may instead contain Potassium Chloride Inj. 10 mEq (NDC 0990-7074-26, Lot 1035181), a highly concentrated formulation intended for diluted use only.