Potassium Chloride Inj., 10 Meq Total In 100 Ml Flexible Container, Highly Concentrated 100 Meq/l, Rx Only, Icu Medical, Inc., Lake Forest, Illinois, 60045, Usa, Ndc# 0990-7074-26
Recall Summary ICU Medical is recalling potassium chloride injection vials distributed nationwide because the label on the package incorrectly states the strength as 10 mEq when the actual product contains 20 mEq. This labeling error could lead to incorrect dosing if healthcare providers rely on the outer label instead of the vial itself. The affected product is potassium chloride injection in 100 mL flexible containers with NDC# 0990-7074-26, distributed across all U.S. states.
- Recalling firm
- Otsuka ICU Medical LLC
- Product
- POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
- 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
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-10-29
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/6c6e88bc-c380-47bf-bb09-15bb1ca04c82