Class I — UrgentReported 2025-11-26

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

Reason for Recall

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

Recall Number

D-0181-2026

Classification

Class I

Status

Ongoing