Drug recalled over potentially life-threatening label mix-up

DNY59—Getty Images  iStock

DNY59—Getty Images iStock

This recall is separate from a different blood pressure prescription recall that found a known carcinogen was in the medication.

The labels of the Accord Healthcare bottles say they contain 100 12.5-milligram tablets of hydrochlorothiazide, but they actually contain 100 25-milligram tablets of spironolactone, a drug used to treat heart, liver and kidney failure, the FDA said in a statement issued Monday.

A 100 count bottle of Hydrochlorothiazide Tablets has been found to containSpironolactone tablets which could result in increased potassium levels that could pose life-threatening situations to some people.

The bottle was a part of lot PW05264, and the FDA says it was a potential mix up of labeling.

One side of the pill has an "H", and the other side has a "1".

Anyone unsure if the pills in their hydrochlorothiazide bottle are hydrochlorothiazide should take them back to their pharmacist or to a healthcare professional.

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Accord Healthcare believes no other lots of Hydrochlorothiazide Tablets are involved in the mix-up, which was initially reported by a pharmacy through a product complaint.

Meanwhile, Hydrochlorothiazide is used "as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension".

So far, Accord has received no reports of anyone getting sick.

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.

Accord says it is notifying wholesalers, distributors, and retailers by letter and is arranging for return of all recalled products.

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