POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medic...

FDA Recall #D-0268-2025 — Class I — February 13, 2025

Recall #D-0268-2025 Date: February 13, 2025 Classification: Class I Status: Ongoing

Product Description

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

Reason for Recall

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

Recalling Firm

ICU Medical, Inc. — Lake Forest, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

unknown

Distribution

Nationwide in the USA

Code Information

Lot 1023172, Exp Date: 31 January 2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated