A manufacturing failure led to the recall of more than 11,000 units of a blood pressure medication distributed throughout the country. The measure, detailed in federal records, seeks to mitigate risks to patients’ health.
Inventia Healthcare Limited initiated voluntary market withdrawal action on June 5, specifically involving chlorthalidone tablets USP, in a dosage of 25 mg.
The recall process covers vials containing 100 and 1,000 units, which are distributed in the United States by Rising Pharma Holdings Inc., based in New Jersey.
The Food and Drug Administration (FDA) oversight report revealed that the product does not meet dissolution specifications. This means that the tablets may not disintegrate correctly in the body, compromising the release of the active ingredient and, consequently, the effectiveness in controlling the patient’s blood pressure, a crucial factor for cardiovascular health.
Chlorthalidone is a drug widely used in the treatment of high blood pressure and in the management of fluid retention.
Details about the lots affected by the recall
- Bottles of 100 units: Lot RISA24001, valid until April 2027.
- Bottles of 1,000 units: Lot RISB24002, valid until April 2027.
The total number of units included in this recall operation is 11,460 vials.
To date, the FDA has not issued a formal classification for this recall, nor has it issued an official press release on the matter.
It is recommended that patients using this medication contact their pharmacist or healthcare professional if they suspect they have a bottle from the affected batches. It is essential that consumers do not stop using prescription medications without first obtaining advice from a doctor.