The Food and Drug Administration announced on September 17 that the recent recall of Inventia Healthcare’s chlorthalidone tablets has been elevated to a Class II recall. This action follows a June recall of the same medication and a separate September 3 recall of an additional lot.
What the recall means
A Class II recall indicates that, while the product is unlikely to cause serious health problems, users could experience temporary or medically reversible issues. The FDA’s classification reflects the agency’s assessment that the risk of severe outcomes is remote.
Why the medication was recalled
Inventia Healthcare cited “failed dissolution specifications” as the reason for the recall. Dissolution is the process by which the active ingredient separates from the tablet so the body can absorb it. If a tablet does not dissolve as intended, the patient may not receive the full therapeutic dose, potentially reducing the drug’s effectiveness in lowering blood pressure.
Details of the affected product
The recall involves more than 13,000 bottles of chlorthalidone tablets, each containing 100 tablets of 25 mg strength. The product is labeled as follows:
- Manufacturer: Inventia Healthcare Limited
- NDC: 64980-599-01
- Batch #: RISA24002
- Expiration date: 04/2027
If you have any of these bottles, verify the batch number and expiration date on the label. If you cannot confirm the information, contact your pharmacist for assistance.
What patients should do
Anyone who may have the recalled medication should contact their healthcare provider immediately. Do not stop taking the medication without medical guidance, as uncontrolled high blood pressure can lead to serious complications such as heart attack, stroke, kidney damage, or vision problems.
If you experience any unusual symptoms while taking the medication, inform your doctor right away. Your provider can determine whether an alternative treatment is needed.
Background on chlorthalidone
Chlorthalidone is a diuretic, often called a “water pill,” that helps the kidneys eliminate excess water and salt. By reducing fluid volume, it lowers blood pressure and decreases the risk of organ damage associated with hypertension.
The FDA’s prompt reclassification underscores the agency’s commitment to protecting public health by ensuring that medications meet strict quality standards. Patients are encouraged to stay informed about recalls and to work closely with their healthcare professionals to maintain safe and effective treatment plans.
Original reporting: WESH Orlando — read the source article.
