Home / Recalls / Otsuka ICU Medical LLC / D-0180-2026

D-0180-2026 Class I Ongoing

Recalled by Otsuka ICU Medical LLC — Austin, TX

Recall Details

Product Type: Drugs
Report Date: November 26, 2025
Initiation Date: October 29, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21,696 50mL flexible containers

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

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

Distribution Pattern

US Nationwide.

Code Information

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