Otsuka ICU Medical recalls
FDA enforcement reports naming Otsuka ICU Medical LLC as the recalling firm.
- Recall reports
- 3
- Class I (serious)
- 2
- Most recent report
- Nov 26, 2025
- Nov 26, 2025POTASSIUM CHLORIDE InjDrug · Otsuka ICU Medical LLCLabeling: 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 mEqClass I
- Nov 26, 2025POTASSIUM CHLORIDE InjDrug · Otsuka ICU Medical LLCLabeling: 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 mEqClass I
- Nov 5, 20250.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, I…Drug · Otsuka ICU Medical LLCLack of Assurance of Sterility: Potential for flexible container leaks.Class II