Otsuka ICU Medical LLC is recalling approximately 21,696 units of Potassium Chloride Injection because the outer overwrap label may incorrectly state a lower strength (10 mEq) than what is actually inside the container (20 mEq). This labeling error means healthcare providers could unintentionally administer twice the intended dose of potassium chloride. The affected products were distributed nationwide in the United States.
Administering a higher concentration of potassium chloride than intended can lead to hyperkalemia, a condition that can cause serious heart rhythm problems or cardiac arrest, particularly in vulnerable patients.
Recall #: D-0180-2026; Quantity: 21,696 50mL flexible containers
Recall #: D-0181-2026
Incorrect Overwrap label showing 10 mEq Potassium chloride injection
Correct Overwrap label showing 20 mEq Potassium chloride injection
Overwrap and Product Image Mislabeled Example
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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