Drug Safety Alerts

Hydrochlorothiazide 12.5 mg Tablets Consumer-level Recall

8/27/18

On August 27, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of hydrochlorothiazide 12.5 mg tablets manufactured by Accord Healthcare Inc. This recall was issued because a bottle of hydrochlorothiazide 12.5 mg tablets contained spironolactone 25 mg tablets. This recall affects lot number PW05264. 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.

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. 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.

Accord’s hydrochlorothiazide 12.5 mg tablets are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side.

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who may have taken recalled product to contact their prescriber.

For more information, health care providers may contact Accord Healthcare toll-free at 1-855-869-1081, Monday through Friday, 8:00 am to 5:00 pm (ET). You may also call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov/Safety/Recalls/ucm618583.htm.