A potentially life-threatening label mix-up has led to a nationwide recall of a high blood pressure medication, according to the U.S. Food and Drug Administration.
Accord Healthcare Inc. is voluntarily recalling one lot of 12.5 mg hydrochlorothiazide tablets after a 100-count bottle of the drug was found to contain 100 tablets of another drug, spironolactone.
Both medications are used to treat high blood pressure, but the FDA warns that taking spironolactone instead of hydrochlorothiazide could pose the risk of hyperkalemia, or an unsafe increase in potassium levels, in some people. This can result in "adverse events that range from limited health consequences to life-threatening situations in certain individuals," the FDA said in a statement.
So far, Accord has received no reports of anyone getting sick.
The company became aware of the mix-up through a complaint reported from a pharmacy.
Only a single lot of the drug, labeled PW05264, is being recalled.
"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," the FDA says.
Accord is reaching out to wholesalers, distributors and retailers by letter and is arranging for return of all recalled products.
The hydrochlorothiazide tablets are light orange to peach colored, round, and debossed with an "H" on one side and a "1" on another side.
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.
Consumers or pharmacies with questions regarding this recall can contact Accord Healthcare, Inc. by phone at 1-855-869-1081 or e-mail at email@example.com.