← FDA ENFORCEMENT
D-0180-2026Class I

Otsuka ICU Medical LLC

Recalling firm
Otsuka ICU Medical LLC
Product type
Drug
Status
Ongoing
Report date
2025-11-26
Distribution
US Nationwide.
Firm state
TX
Product quantity
21,696 50mL flexible containers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.