Drug product
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
D-0180-2026
Product summary
- Event
- Event 97888
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 21,696 50mL flexible containers
- Official record key
drug-enforcement:D-0180-2026
Official wording
Reason: Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Code information: Lot # 1030613, Exp Date: 09/30/2026
Distribution pattern: US Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error