← Every firm
Otsuka ICU Medical LLC FDA Recalls
3 recalls on file across drugs, 2 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical,Class IOct 29, 2025Labeling: Label Error on Declared Strength-The overwrap labe |
| POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Class IOct 29, 2025Labeling: Label Error on Declared Strength-The overwrap labe |
| 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-798Class IIOct 27, 2025Lack of Assurance of Sterility: Potential for flexible conta |