Drug 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
D-0267-2025
Product summary
- Event
- Event 96250
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 67,488 flexible containers
- Official record key
drug-enforcement:D-0267-2025
Official wording
Reason: 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.
Code information: Lot 1023172, Exp Date: 31 January 2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
mislabeled