Labeling Mix-Up Prompts Recall of HCTZ Bottles That May Contain Another Diuretic

Accord Healthcare announced a voluntary recall of 1 lot of Hydrochlorothiazide tablets USP, 12.5mg, after a product complaint from a pharmacy stated that the bottle contained Spironolactone Tablets USP, 25mg. 

The recalled 100-count bottle of Hydrochlorothiazide has Lot #PW05264-46632 (NDC 16729-182-01). The Company believes no other lots were affected in the mix-up according to investigations conducted at the manufacturing site. 

Hydrochlorothiazide, a thiazide diuretic, is indicated for the management of hypertension as monotherapy or in combination with other antihypertensive drugs for more severe forms of hypertension. It is also indicated for the management of edema. 

Spironolactone, a potassium-sparing diuretic, is indicated for 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, and severe heart failure. 

If spironolactone is taken instead of hydrochlorothiazide, patients may be at risk of hyperkalemia resulting in minor to life-threatening adverse events. To date, there have been no reports of any adverse events related to this recall.  

For more information call (855) 869-1081 or visit AccordHealthcare.us or the FDA Safety Alert.

This article originally appeared on MPR