A prescriber ordered a potassium chloride 10 mEq/100 mL infusion for a patient with a peripheral intravenous (IV) line. The nurse removed a bag from the automated dispensing cabinet (ADC) labeled potassium chloride 10 mEq/100 mL (NDC 0990-7074-26) by ICU Medical and scanned the barcode on the overwrap. The nurse opened the overwrap, read the infusion bag label, and identified that it was labeled potassium chloride 20 mEq/50 mL (NDC 0990-7077-14, lot number 1030613) (Figure 1). The hospital quarantined the overwrap and infusion bag and notified ICU Medical. The hospital did not find additional infusion bags with this issue.

Carton label with product and manufacturing details — **Figure 1.** A hospital reported that ICU Medical’s overwrap labeled potassium chloride injection 10 mEq/100 mL contained an infusion bag labeled potassium chloride injection 20 mEq/50 mL.

On February 13, 2025, ICU Medical issued a recall of potassium chloride injection due to mislabeling involving a different lot number (1023172). An overdose of potassium chloride can lead to patient harm, including hyperkalemia and cardiac dysrhythmia. If the more highly concentrated potassium chloride product is inadvertently infused via a peripheral IV line, this could also lead to vein irritation and pain.

We have reached out to the US Food and Drug Administration (FDA) and ICU Medical to notify them of this concern. ICU Medical informed us that they are conducting an investigation. If your organization has purchased this product, notify staff to be vigilant when checking the infusion bag labels for all ICU Medical’s potassium chloride injection bags prior to barcode scanning and administration, regardless of the lot. If impacted product is found, sequester it until the manufacturer provides further instructions. While this is an unusual situation, the best practice is to scan the barcode directly on an infusion bag (not the overwrap) prior to administration. Report issues to ISMP, FDA, and ICU Medical.

Suggested citation:
Institute for Safe Medication Practices (ISMP). Warning! Overwrap labeled potassium chloride 10 mEq/100 mL may contain potassium chloride 20 mEq/50 mL premixed IV bag. ISMP Medication Safety Alert! Acute Care. 2025;30(17):1-2.

Warning! Overwrap Labeled Potassium Chloride 10 mEq/ 100 mL May Contain Potassium Chloride 20 mEq/ 50 mL Premixed IV Bag