← FDA ENFORCEMENT
D-0268-2025Class I

ICU Medical, Inc.

Recalling firm
ICU Medical, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-03-19
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
unknown
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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

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

Code / lot info

Lot 1023172, Exp Date: 31 January 2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.