The affected product is a 100-count bottle of 12.5 milligram hydrochlorothiazide tablets, which instead contained 100 spironolactone tablets.
While both hydrochlorothiazide and spironolactone can be used to treat high blood pressure, spironolactone causes the body to store potassium and flush out excess water and sodium. As a result, patients mistakenly taking spironolactone are at risk of hyperkalemia, or elevated potassium levels, which can result in “adverse events that range from limited health consequences to life-threatening situations in certain individuals,” the recall notice reads.
To date, the drugmaker has not received reports of adverse events in connection with the labeling mix-up.
Accord is notifying wholesalers, distributors and retailers by letter. Consumers who have the wrong product should return the product to the pharmacy for a refund.
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