Blood pressure drug recalled over potentially life-threatening label mix-up

DNY59—Getty Images  iStock

DNY59—Getty Images iStock

Accord believes the medication was only switched in lot PW05264.

Accord Healthcare, voluntarily recalling a single lot of mislabeled 100-count bottles of hydrochlorothiazide 12.5 mg tablets.

The FDA says there could be a labeling mix-up, after finding a bottle filled with different medication inside.

Accord's tablets are round, light peach-colored pills with an "h" on one side and the number "1" on the other.

A blood pressure medication has been recalled after the US Food and Drug Administration (FDA) discovered that bottles of it contained another drug.

The company became aware of the mix-up through a complaint reported from a pharmacy. However, using spironolactone tablets instead of hydrochlorothiazide tablets could increase the risk of contracting hyperkalemia (elevated potassium levels), which could trigger other adverse events of varying degrees of severity depending on the person.

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Hydrochlorothiazide is used to treat high blood pressure "as the sole therapeutic agent or to enhance the effectiveness of other anti-hypertensive drugs in the more severe forms of hypertension", the recall notice reads.

If the tablets in a bottle of Accord hydrochlorothiazide 12.5 mg do not match this description, or if consumers are unsure, they should return to their pharmacy or health care provider for confirmation, the FDA said.

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

Accord is reaching out to wholesalers, distributors and retailers by letter and is arranging for return of all recalled products.

Wholesalers, distributors, and retailers that have the recalled product have been advised to discontinue distribution of the product and notify consumers.

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