Accord Healthcare Inc. Recalls Hydrochlorothiazide Tablets USP 12.5 Mg

News
Article

The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.

On Aug. 27, 2018, Accord Healthcare Inc. announced it was voluntarily recalling one lot of Hydrochlorothiazide Tablets USP, 12.5 mg. The recall was initiated after a pharmacy complained that a 100-count bottle of Hydrochlorothiazide Tablets USP 12.5 mg contained 100 Spironolactone Tablets USP 25 mg instead. After preliminary and interim investigations, the company believes no other lots of Hydrochlorothiazide Tablets are affected.

Hydrochlorothiazide tablets are used to manage hypertension either alone or with other antihypertensive drugs. Spironolactone tablets are used to treat 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. According to the company, “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.”

Accord stated in a press release that it has not received any reports of adverse events. Adverse events may be reported to FDA through its MedWatch program.

Source: FDA

 

Recent Videos
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.