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High severity

POTASSIUM 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

SourceFDA Drug Enforcement
CategoryDrug
SeverityHigh
Statusongoing
Recall dateOctober 29, 2025
ReportedNovember 26, 2025
Recalling firmOtsuka ICU Medical LLC
Country / regionUnited States TX

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

Affected products

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