⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Otsuka ICU Medical LLC: POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,

DrugsSource: FDA (drug) · Date: 2025-11-26

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Otsuka ICU Medical LLC
Product
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 / 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
Classification
Class I
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2025-10-29
Code info
Lot # 1030613, Exp Date: 09/30/2026
Voluntary mandated
Voluntary: Firm initiated
City
Austin
State
TX
Country
United States
Event id
97888
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