FDA DrugClass I

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

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.

From the FDA notice · Read the official notice ↗ · All ICU Medical recalls

What to do

The agency's notice has the remedy and who to contact.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected
21,696 50mL flexible containers
Illnesses reported
None reported
Manufactured in
3900 Howard Ln, Austin, TX, United States
Classification
Class I
Recall number
D-0180-2026

In the FDA's words

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 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 Lot # 1030613, Exp Date: 09/30/2026 Distribution: US Nationwide. Affected quantity: 21,696 50mL flexible containers
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

2 products in this recall

The agency lists each product separately. Check every one you might have.

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