Blood pressure medicine recalled over label mix-up concern

Potentially Life Threatening Issues Lead to Voluntary Medicine Recalls

Potentially Life Threatening Issues Lead to Voluntary Medicine Recalls

A drug maker has announced a voluntary recall of one of its medications used for treatment of hypertension.

According to the FDA, the recall involves certain bottles of 12.5 mg hydrochlorothiazide tablets after a 100-count bottle of the drug was found to contain a different medicine.

Instead of the blood pressure medication hydrochlorothiazide, the bottles were filled with 100 tablets of 25 mg USP spironolactone, which is used to treat congestive heart failure and cirrhosis.

Accord does not believe that other lots of hydrochlorothiazide are involved in the mix-up, the FDA said, adding that Accord learned of the error after a pharmacy alerted the company.

Tablets of hydrochlorathiazide are circular, light peach in color and have a "1" etched on one side and an "H" on the other.

The FDA says if you have a hydrochlorothiazide prescription and the pills in your bottle do not match that description, or if you are unsure, return them to your pharmacy or doctor.


Spironolactone is commonly used to treat fluid retention, or edema, in patients with heart, liver and kidney failure.

But, Accord said they have not received any reports of adverse reaction related to the mix up.

"Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increased potassium levels) in certain individuals resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals", the notice explains.

Medication in that lot is now under a voluntary recall.

Accord is also reaching out to pharmacists and retailers, as well as wholesalers and distributors.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug.

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