(9/3/18) A drug used to treat high blood pressure is being recalled due to a potentially life-threatening label mixup.
Accord Healthcare is recalling one lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.
A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg.
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. Accord became aware of this finding through a product complaint reported from a pharmacy.
Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure.
Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in certain individuals resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals. To date, Accord has not received any reports of adverse events related to this recall.
Hydrochlorothiazide tablets are indicated in the management of hypertension.
Accord’s Hydrochlorothiazide Tablets USP 12.5 mg are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side.
If you are in possession of Accord Hydrochlorothiazide that does not match this image or if you are unsure, please return to your pharmacy or healthcare provider for confirmation.
Consumers/Pharmacies with questions regarding this recall can contact Accord Healthcare, Inc. by phone at 1-855-869-1081, fax: 1-817-868-5362 or e-mail at firstname.lastname@example.org Monday to Friday during business hours 8 am to 5 pm EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.