POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L,...
FDA Recall #D-0180-2026 — Class I — October 29, 2025
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
Recalling Firm
Otsuka ICU Medical LLC — Austin, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
21,696 50mL flexible containers
Distribution
US Nationwide.
Code Information
Lot # 1030613, Exp Date: 09/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated