The U.S. FDA CVM shares the recall announcement of the potassium chloride injection that may be potentially used in veterinary settings. Photos courtesy FDA CVM The U.S. Food and Drug Administration (FDA)'s Center for Veterinary Medicine (CVM) has shared an announcement regarding a voluntary recall by ICU Medical, Inc. of one lot of POTASSIUM CHLORIDE Injection bags. The recall involves 20 mEq bags mistakenly labeled with overwraps indicating a concentration of 10 mEq. This labeling error, caused by a manufacturing issue, may not be immediately noticeable since the correct 20 mEq labeling is only visible on the bag after removing or manipulating the overwrap. The mislabeled product reportedly poses a significant risk if healthcare providers calculate dosing based on the incorrect 10 mEq label, potentially leading to an overdose of potassium chloride. Vulnerable populations include premature infants, patients with renal insufficiency or failure, those on potassium-sparing diuretics, individuals with a history of cardiac arrhythmias, and patients receiving chronic parenteral nutrition. Since potassium chloride injections may be used in veterinary settings, the FDA CVM is sharing this information to alert veterinary professionals to the potential risk. The affected product—Potassium Chloride Injection 20 mEq/100 mL—is used for potassium deficiency when oral supplementation is not possible. The mislabeled bags have an overwrap displaying incorrect details: NDC 0990-7074-26, 200 mEq/L, POTASSIUM CHLORIDE Inj. 10 mEq. The actual lot number is 1023172, with an expiration date of January 31, 2026. These mislabeled bags are distributed in cases labeled with NDC 0990-7075-26 and the same lot number and expiration date. For more information on product details and photos, visit the FDA website.
