More than 11,000 bottles of blood pressure medication have been recalled because they failed quality control testing.
On June 5, an Indian healthcare company issued a recall of 100 and 1000 tablet bottles of chlorthalidone 25 mg because the medication failed quality testing that measures how the drug dissolves in the body, according to an enforcement report by the U.S. Food and Drug Administration.
Chlorthalidone is used to treat high blood pressure, a condition that increases the risk of heart attacks and strokes, according to Mayo Clinic.
Dissolution specifications refer to testing the release and stability of an oral drug product under certain conditions. This is an important step in the development and formulation of pharmaceutical dosage forms, according to the International Pharmaceutical Industry.
The recall was classified as a Class II recall on June 22, meaning the product could cause temporary or reversible health problems.
The affected products were manufactured by Inventia Healthcare Limited and distributed by New Jersey-based Risiong Pharma Holdings, Inc.
The recalled bottles have an expiration date of April 2027. The 100 tablet bottle has batch code RISA24001, while the 1000 tablet bottle has batch code RISB24002.
Anyone who takes prescription blood pressure medication should check the label on the bottle.