Brand
Otsuka ICU Medical LLC
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Otsuka ICU Medical LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-11-26FDA-DrugClass IPOTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
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
- 2025-11-26FDA-DrugClass IPOTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
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
- 2025-11-05FDA-DrugClass II0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lack of Assurance of Sterility: Potential for flexible container leaks.
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