United StatesPOTASSIUM CHLORIDE Injection, 20 mEq total in 50 mL flexible container (highly concentrated 400 mEq/L), Rx only, ICU Medical (NDC 0990-7077-14), Lot #1030613, Exp. 09/30/2026, distributed nationwide (21,696 units) may have an overwrap label that incorrectly identifies it as POTASSIUM CHLORIDE 10 mEq. The product is being recalled because of this labeling error that could misidentify the declared strength.
What's being recalled
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
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
Recalling firm: Otsuka ICU Medical LLC, Austin, TX, United States.
How to identify it
Lot # 1030613, Exp Date: 09/30/2026
The hazard
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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)