Home / Brands / Otsuka ICU Medical
Otsuka ICU Medical Recalls
3 recalls on record · November 5, 2025 to November 26, 2025 · Drugs
November 26, 2025DrugsFDA
Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical,
Hazard: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
November 26, 2025DrugsFDA
Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,
Hazard: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
November 5, 2025DrugsFDA
Otsuka ICU Medical LLC recalls 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798
Hazard: Lack of Assurance of Sterility: Potential for flexible container leaks.