Drug recall D-0180-2026

Class I Ongoing reported Nov 26, 2025

Product

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

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

Lots and codes

Lot # 1030613, Exp Date: 09/30/2026

Recall details

Recalling firm
Otsuka ICU Medical LLC, Austin, TX
Quantity
21,696 50mL flexible containers
Distribution
US Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
October 29, 2025

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