FDA Recalls Over 25K Blood Pressure Meds Over Safety Concerns
FDA issues recall of 25,000 blood pressure medication bottles due to dissolution issues.
2 min read
The U.S. Food and Drug Administration (FDA) has issued a recall for over 25,000 bottles of blood pressure medication due to ‘failed dissolution specifications,’ which may affect the drug’s effectiveness. The recalled medication is 25-milligram chlorthalidone tablets manufactured by Inventia Healthcare Limited, based in Mumbai, India, and sold in 100-count bottles.
Recall Details and Health Implications
The recall has been classified as a Class II recall, indicating that the use of the affected product may lead to temporary or medically reversible health issues. While there have been no reported illnesses linked to this recall, the FDA advises individuals to seek medical attention if they have any health concerns.
The affected bottles contain the National Drug Code (NDC) ‘64980-599-01,’ batch number ‘RISA24002,’ and an expiration date of ‘4/2027.’ The recall includes approximately 13,567 bottles, with a secondary recall affecting an additional 11,460 bottles. Inventia Healthcare initially issued the recall on June 5th and expanded it on September 3rd.
What is Chlorthalidone?
Chlorthalidone is a diuretic used to lower blood pressure by reducing the amount of water and salt in the body, thereby increasing urine flow. According to the Mayo Clinic, it is commonly prescribed for hypertension management. However, the dissolution issues may impact how the drug is absorbed in the body, potentially reducing its effectiveness.
Public Health Concerns
Approximately half of adult Americans have high blood pressure, as reported by the Centers for Disease Control and Prevention (CDC). Hypertension is defined as a blood pressure reading of 130 mm Hg/80 mm Hg or higher, and it significantly increases the risk of heart disease and stroke, which are leading causes of death in the U.S.
The FDA has provided contact information for further inquiries, including a phone number for the agency. Patients are urged to check their medication and consult with healthcare providers if they have any concerns about the recalled product.
Source: OANN
