WhichRecall
Class I — UrgentReported 2025-11-26

POTASSIUM 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

Recalled by Otsuka ICU Medical LLC

Reason for Recall

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj

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10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

Recall Number
D-0180-2026
Classification
Class I
Status
Ongoing
Category
drug
Initiated
2025-10-29
Reported
2025-11-26
Distribution
US Nationwide.
Code Info
Lot # 1030613, Exp Date: 09/30/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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