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The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.
On Aug. 27, 2018, Accord Healthcare Inc. announced it was voluntarily recalling one lot of Hydrochlorothiazide Tablets USP, 12.5 mg. The recall was initiated after a pharmacy complained that a 100-count bottle of Hydrochlorothiazide Tablets USP 12.5 mg contained 100 Spironolactone Tablets USP 25 mg instead. After preliminary and interim investigations, the company believes no other lots of Hydrochlorothiazide Tablets are affected.
Hydrochlorothiazide tablets are used to manage hypertension either alone or with other antihypertensive drugs. Spironolactone tablets are used to treat 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, and severe heart failure. According to the company, “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.”
Accord stated in a press release that it has not received any reports of adverse events. Adverse events may be reported to FDA through its MedWatch program.