FDAFebruary 13, 2025drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
icu medicalicu
UPCs
0030990707526630309907075267
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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