PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: March 19, 2025 Initiated: February 13, 2025 #D-0268-2025

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

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
unknown
Distribution
Nationwide in the USA
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by ICU Medical, Inc.. Units affected: unknown.
Why was this product recalled?
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Which agency issued this recall?
This recall was issued by the FDA Drug on March 19, 2025. Severity: Critical. Recall number: D-0268-2025.