TOPIC: Potassium Chloride Injection, 10 mEq and 20 mEq by ICU Medical: Recall - Due to Mislabeling
AUDIENCE: Patient, Health Care Professional, Pharmacy
ISSUE: ICU Medical is recalling one lot102 3172, each of Potassium Chloride Injection bags with overwrap labels 10 mEq, packaged in cases of Potassium Chloride Injection 20 mEq because ICU Medical received a customer complaint which states that bags of Potassium Chloride Injection 20 mEq have incorrect overwrap labels which state Potassium Chloride Injection 10 mEq.
ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V. Bag) of Potassium Chloride due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place
Risk Statement: If the Health Care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride. Severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes.
ICU Medical has not received reports of adverse events associated with this issue to date.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Potassium Chloride Injection 10 mEq and 20 mEq, is indicated for the treatment of potassium deficiency, when oral replacement is not feasible.
RECOMMENDATIONS:
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Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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Patients with questions regarding this recall can contact ICU Medical by phone number or e-mail address as indicated in the recall.
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All health care professionals that have product that is being recalled should stop use/further distribution, as applicable, and return to place of purchase.
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