The FDA upgraded a recall of chlorthalidone blood pressure tablets. The pills failed a test measuring proper drug dissolution.
The U.S. Food and Drug Administration has classified a recall of more than 13,500 bottles of chlorthalidone blood pressure tablets as a Class II recall, the agency’s second-highest classification. The recalled medication, manufactured by Mumbai-based Inventia Healthcare Limited, covers Chlorthalidone Tablets, USP, 25 mg, in 100-count bottles bearing lot number RISA24002 with an expiration date of April 2027. Inventia voluntarily began the recall Sept. 3, and the FDA classified it Sept. 17.
The recall was issued after the tablets failed dissolution testing, which measures how completely and how quickly a drug releases its active ingredient so the body can absorb it. According to the FDA, a tablet that does not meet dissolution specifications may not deliver its intended dose, potentially making the medication’s effect less predictable. Neither Inventia Healthcare nor the FDA has released further detail on what caused the tablets to fail the test. The FDA said a Class II recall means use of the affected product may cause temporary or medically reversible health problems, with the likelihood of serious harm considered remote.
This is the second chlorthalidone recall tied to the same dissolution issue this year. Inventia recalled roughly 11,000 bottles from an earlier lot in June, also classified as Class II, and the FDA upgraded that recall’s status this month. Chlorthalidone is a diuretic commonly prescribed to treat high blood pressure and fluid retention, and is sometimes used for patients with kidney disease, heart failure or cirrhosis. The recall affects specific lots from one manufacturer, and most patients taking chlorthalidone are not affected. Patients can check their pharmacy label or original bottle for the lot number and National Drug Code, and the FDA and medical experts advise against stopping the medication without first consulting a doctor or pharmacist, given the health risks of discontinuing blood pressure treatment abruptly.
Sources: This report is based on information from the Associated Press (via Dallas Morning News), Yahoo News and AOL.