Recall
FDAHealthFebruary 13, 2025

ICU Medical, Inc. — 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

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
February 13, 2025

Nationwide in the USA

What's affected?

Product
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
Lot code
1023172

Additional details

Lot 1023172, Exp Date: 31 January 2026

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 67,488 flexible containers.

View original FDA notice →

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