Accord Healthcare, Inc., is recalling 12.5-milligram hydrochlorothiazide pills after a 100-count bottle of the drug was found instead to contain 25-milligram doses of spironolactone, a different drug.
The tablets are supposed to be light orange or peach in color and round.
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.
The Food and Drug Administration (FDA) is warning of a blood pressure drug labeling mix-up that could have effects ranging from "limited" to "life-threatening", depending on the individual.
Accord stated in a press release that it has not received any reports of adverse events.
The mislabeled bottles actually contain Spironolactone tablets which could cause in an increase in potassium levels in certain individuals. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up.
Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Wholesalers, distributors, and retailers that have the recalled product have been advised to discontinue distribution of the product and notify consumers.