FDA issues recall on mislabeled medication
In this DML Report…
Otsuka ICU Medical LLC, based in Texas, has initiated a voluntary recall of one lot of Potassium Chloride (KCl) Injection, 20 mEq, due to mislabeling on the outer packaging. The affected lot, numbered 1030613 with an expiration date of September 30, 2026, was manufactured on April 15, 2025, and distributed nationwide between May 23, 2025, and August 26, 2025. The NDC code is 0990-7077-14, but the overwrap incorrectly lists it as 10 mEq under NDC 0990-7074-26, while the inner bag label correctly states 20 mEq. This medication treats and prevents hypokalemia, affecting about 30 million Americans, and is administered intravenously in hospitals or clinics for patients unable to take oral forms or needing quick replenishment. It is a highly concentrated, ready-to-use solution for those with fluid restrictions, requiring slow infusion, cardiac monitoring, and frequent potassium level checks.
The mislabeling could lead to administration errors, where the 20 mEq dose is mistaken for 10 mEq, resulting in an overdose and hyperkalemia. Symptoms include neuromuscular issues like muscle weakness or paralysis, listlessness, confusion, low blood pressure, cardiac arrhythmias, or cardiac arrest. Higher risks apply to premature infants, patients on long-term parenteral nutrition, those with cardiac arrhythmia history, or individuals with renal impairment or failure. No adverse events have been reported to date.
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The recall stems from a manufacturing issue identified by the company. Healthcare professionals and facilities should inspect inventory, quarantine the affected lot—identifiable by the lot number on the bag's top left or case label—and follow recall instructions. Contact Otsuka ICU Medical LLC customer service or review the official notice for further details or reporting.