POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only,...
FDA Recall #D-0267-2025 — Class I — February 13, 2025
Product Description
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
Reason for Recall
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
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
67,488 flexible containers
Distribution
Nationwide in the USA
Code Information
Lot 1023172, Exp Date: 31 January 2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated