Some 12.5 mg Hydrochlorothiazide Tablets USP Recalled; Bottle May Contain Another Medication
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Some 12.5 mg Hydrochlorothiazide Tablets USP Recalled; Bottle May Contain Another Medication

One lot has been found to contain Spironolactone tablets instead of the intended medication

August 29, 2018

Accord Healthcare Inc. is voluntarily recalling one lot of 12.5 mg Hydrochlorothiazide Tablets USP. The medication bottle may contain another medication.

Bottles May Contain Another Medication

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg was found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. 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.

Use of Spironolactone

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.

Uses of Hydrochlorothiazide

Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other anti-hypertensive drugs in the more severe forms of hypertension.

Hydrochlorothiazide Tablet Description

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 description or if you are unsure, please return to your pharmacy or healthcare provider for confirmation.

Stop Use and Return to Pharmacy

Accord is notifying its Wholesalers, Distributors and Retailers by letter and is arranging for return of all recalled products. Wholesalers, Distributors, and Retailers that have product which is being recalled should discontinue distribution of the product and notify consumers. Consumers that have the product should return the product to the pharmacy.

If you have questions

Consumers with questions regarding this recall can contact Accord Healthcare, Inc. at (855) 869-1081. 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.