Drug product
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
D-0268-2025
Product summary
- Event
- Event 96250
- Status
- Ongoing
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-0268-2025
Official wording
Reason: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Code information: Lot 1023172, Exp Date: 31 January 2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Error