FDA Recalls Chlorthalidone Tablets Over Dissolution Issues
FDA Issues Recall for Chlorthalidone Blood Pressure Tablets
The U.S. Food and Drug Administration (FDA) has announced a Class II recall of chlorthalidone blood pressure tablets following the failure of more than 13,000 bottles in dissolution testing.
Importance of Dissolution Testing
A failure in dissolution testing indicates that the tablets did not dissolve adequately in the body, which can compromise their effectiveness in treating patients. Proper dissolution is essential for the medication to be absorbed correctly.
Details of the Recall
Initiated by Inventiva Healthcare Limited on September 3, the FDA officially classified the recall on September 17. The Class II designation suggests that while the product may lead to temporary or reversible health issues, the risk of severe harm is low.
- Number of Bottles: 13,567
- Product: Chlorthalidone tablets, USP, 25 mg
- NDC: 64980-599-01
- Batch Number: RISA24002
- Expiration Date: April 2027
- Distribution: Nationwide
Potential Health Risks
Due to the reduced effectiveness of these tablets, there is an increased risk of serious health complications, including heart attack, stroke, and kidney damage, if the condition remains untreated.
Previous Recalls
This is the second recall of chlorthalidone this year. In June, Inventiva Healthcare recalled 11,460 bottles of the same medication, available in both 100-tablet and 1,000-tablet sizes, for similar dissolution issues. That recall was also classified as Class II.
“Patients taking chlorthalidone should consult their healthcare provider for guidance on alternative treatments and next steps.”
Source Reference (geo.tv): Blood pressure medication recall: What patients need to know about Clorthalidone