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August 27, 2018: Accord Healthcare Recalls Hydrochlorothiazide Tablets – One Lot

Accord Healthcare Recalls Hydrochlorothiazide Tablets

Accord Healthcare Inc., has recalled one lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, due to a potential product labeling error. Specifically, a 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg was found to contain 100 Spironolactone Tablets USP 25 mg, according to the company’s recall announcement. Accord Healthcare became aware of the mix-up through a product complaint reported from a pharmacy.

About Spironolactone and Hydrochlorothiazide

Accord Healthcare provided the following medication information to consumers:

“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 either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.”

Accord Hydrochlorothiaide Tablet Description and Consumer Advice

Accord Hydrochlorothiazide Tablets, 12 mg


Accord 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. See image at left.

The company stated in its press release “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.

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.

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 rxrecalls@inmar.com 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.”

MedWatch Adverse Event Reporting

Adverse reactions or quality problems experienced with the use of Accord Healthcare Hydrochlorothiazide Tablets, 12.5 mg or any other drug product, may be reported to the FDA’s MedWatch Adverse Event Reporting program.

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