Critical hospital drug recalled over potential to cause death by overdose

A drug used for millions of patients at hospitals has been recalled over a risk of causing overdose and death due to a labeling error.

ICU Medical is voluntarily recalling its IV bags of potassium chloride after discovering that one of lot of the product was mislabeled.

‘ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq,’ stated an advisory published by the US Food and Drug Administration last Friday.

The label could lead a health care provider to calculate the wrong amount to administer to a patient and give them too much.

Huge overdoses could cause neuromuscular disfunction which includes paralysis, confusion, weakness and even cardiac arrest leading to death.

‘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,’ states the advisory.

No illness has yet been reported linked to the IV bags.

The manufacturer has informed distributors and customers by letter and requested them to return the product.

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