Labeling Error Leads to Recall

Prepackaged bottles of Spironolactone were found to have incorrect dosage information printed on them.

When you consider the vital information for drug packaging, dosage is near the top of this list. A recent FDA Safety article noted Bryant Ranch Prepack’s voluntary recall of 47 bottles of Spironolactone tablets at the consumer level due to a labeling issue. Spironolactone is a diuretic used to treat high blood pressure, heart failure, hypokalemia, and edema. Apparently the packaging was mislabeled, and bottles labeled 50 mg may actually contain 25 mg tablets, and vice versa.

If patients inadvertently take a smaller dose, they could experience heightened blood pressure, swelling, and a decrease in potassium that could lead to Hypokalemia. And if patients take twice the intended dose, they could experience a life-threatening increase in potassium. 

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