ICU Medical Recalls Potassium Chloride Injection Due to Labeling Error
ICU Medical, Inc has issued a voluntary nationwide recall of potassium chloride injection 20 mEq in 100 mL flexible containers due to a labeling error affecting the declared strength of the product. While the flexible container itself correctly displays the 20 mEq concentration, the overwrap label may be mislabeled as 10 mEq, posing a risk of dosing confusion. This discrepancy could lead to underdosing or delays in patient treatment, particularly in critical care settings where accurate electrolyte replacement is essential. The recall affects 67 488 flexible containers from lot #1023172, which has an expiration date of January 31, 2026.
The US Food and Drug Administration has classified this recall as Class I, indicating that the mislabeled product could cause serious health consequences or death if improperly dosed. ICU Medical, Inc, headquartered in Lake Forest, Illinois, initiated the recall voluntarily on February 13, 2025, notifying health care providers through an official letter.
Potassium chloride injection is an essential electrolyte replacement therapy used to treat hypokalemia (low potassium levels in the blood), which can result from conditions such as prolonged vomiting, diarrhea, or certain medication side effects. Proper potassium balance is crucial for cardiac function, nerve signaling, and muscle contraction. Given the high-alert nature of potassium chloride in clinical settings, pharmacists must ensure accurate dispensing and administration. Health care professionals are urged to verify the correct dosage strength on the flexible container itself before administration.
