Written by:Eli Ben-Yehuda, September 2, 2018
A Voluntary Recall

Another blood pressure medication has been recalled after the wrong pills were found in the bottle. This is just weeks after blood pressure medications were recalled due to impurities. This mix up is potentially life-threatening.

Accord Healthcare Inc. is voluntarily recalling 1 lot of Hydrochlorothiazide Tablets USP, 12.5 mg, at the consumer level, due to a potential labeling mix-up. According to the company, the lot (PW05264) of 100-count bottles of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg.

Accord was made aware of the issue with Lot PW05264 through a product complaint reported from a pharmacy. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, company officials said, in a press release, that it believes no other lots of Hydrochlorothiazide Tablets are involved in this mix-up.

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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 the condition. 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 increased potassium levels in certain individuals. This can result 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 the recall of Lot PW05264.

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. The company is encouraging consumers in possession of Accord Hydrochlorothiazide that does not match the description, or who are unsure, to return with it to their pharmacy or consult a health care provider for confirmation.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.

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 a 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 are certain your bottle contains the wrong pills, return them to your pharmacy, the FDA says.

You can also contact Accord at 855-869-1081. Or you can email [email protected]

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FDA Recalls Expand: Valsartan and Hydrochlorothiazide

A popular drug used to treat high blood pressure has been recalled because some products may contain a cancer-causing chemical.

In an ongoing investigation, the Food and Drug Administration has expanded the swath of the recall of the drug Valsartan, which is used to treat high blood pressure and heart failure. The recalled drugs, manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, contain the chemical N-nitrosodimethylamine, or NDMA. This chemical has been found to cause cancer in humans based on laboratory studies, the agency says.

Last month, the FDA issued a voluntary recall for some Valsartan tablets and had since expanded it twice to include additional products from more drug companies, as well as some tablets with Valsartan and hydrochlorothiazide (HCTZ).

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