Key Takeaway:
- Inventia Healthcare recalled 13,567 bottles of 25-mg chlorthalidone tablets over dissolution issues.
- The FDA classified the recall as Class II, indicating serious health consequences are considered unlikely.
- Inventia previously recalled more than 11,400 bottles of the same drug in June for identical issues.
Blood Pressure Drug Recalled nationwide after Inventia Healthcare is recalling 13,567 bottles of 25-milligram chlorthalidone tablets after quality testing found the medication failed to dissolve properly.
Inventia Recalls Thousands Of Chlorthalidone Bottles
The Blood Pressure Drug Recalled by Inventia Healthcare is a 25-milligram chlorthalidone product packaged in bottles containing 100 tablets. The medication is used to treat high blood pressure and fluid retention. The affected product carries National Drug Code 64980-599-01 and expires in April 2027, according to the U.S. Food and Drug Administration.
The FDA classified the recall as Class II, a designation used when exposure to a violative product may cause temporary or medically reversible health consequences, or when the likelihood of serious harm is considered remote.
The dissolution problem can affect how a tablet releases and becomes available in the body, making proper dissolution an important part of drug quality testing.
FDA Classifies Recall As Class II
The FDA’s recall classification does not mean every person who takes the affected medication will experience an adverse reaction. The agency’s Class II category covers a range of potential risks and indicates that serious health consequences are considered unlikely.
Chlorthalidone belongs to a group of medicines known as diuretics, which help the body remove excess salt and water. It is commonly used to help manage high blood pressure and fluid retention.
Patients who believe they have an affected product should check the medication’s label and recall information and consult a health care professional or pharmacist before making changes to prescribed treatment.
The FDA advises consumers and health care professionals to report problems involving medical products through its reporting system.
Inventia Previously Recalled Same Drug
The latest action follows a similar recall by Inventia Healthcare in June involving more than 11,400 bottles of the same medication. That earlier recall also cited dissolution issues.
The repeated recalls put the focus on quality testing for the widely used medication, although the FDA’s Class II designation indicates the agency considers the probability of serious adverse health consequences remote.
Inventia Healthcare, an India-based pharmaceutical company, initiated the latest recall voluntarily. FOX Business reported that it contacted the company for comment, but no response was included in the report.
The FDA enforcement report identifies the affected product by its dosage, package size, National Drug Code and expiration date, allowing consumers and health care providers to distinguish the recalled bottles from other chlorthalidone products.
Consumers should not stop taking prescribed blood pressure medication without speaking with a health care professional, as abruptly changing treatment can affect blood pressure control.
