Key takeaway:
- More than 11,000 bottles of 25 mg chlorthalidone were impacted by Blood Pressure Drug Recalls nationwide due to quality concerns.
- The medication failed dissolution testing, which may make it less effective or deliver an incorrect dose.
- The recall affects lot numbers RISA24001 and RISB24002, both with April 2027 expiration dates.
More than 11,000 bottles of chlorthalidone have been affected by Blood Pressure Drug Recalls across the United States after tests revealed the medication may not dissolve properly, potentially reducing its effectiveness for patients, according to the U.S. Food and Drug Administration.
The recall affects 25-milligram doses of Chlorthalidone manufactured by Inventia Healthcare Limited in India and distributed by Rising Pharma Holdings Inc. of East Brunswick, New Jersey.
The FDA said the medication failed dissolution specifications during quality testing. The issue means the tablets may not release the active ingredient as intended when taken, potentially reducing their effectiveness or resulting in an incorrect dosage.
Recall targets specific lots
The recall applies to two batches of Chlorthalidone packaged in 100-tablet and 1,000-tablet bottles.
According to the FDA notice, the affected lot numbers are RISA24001 for the 100-tablet bottles and RISB24002 for the 1,000-tablet bottles. Both products carry expiration dates of April 2027.
Patients and health care providers are being advised to check medication packaging to determine whether they have received one of the recalled lots.
FDA cites dissolution failure
The FDA said the recall was initiated after the medication failed the required dissolution testing standards. Dissolution testing measures how quickly and completely a drug releases its active ingredient into the body.
“A product that does not meet dissolution specifications may be less effective,” the agency said in its recall notice.
Chlorthalidone is commonly prescribed to treat high blood pressure and lower the risk of cardiovascular complications, but concerns linked to Blood Pressure Drug Recalls highlight that reduced effectiveness could make it harder for some patients to manage their condition.
Manufacturer and distributor respond
Inventia Healthcare Limited manufactured the recalled medication in India, while Rising Pharma Holdings distributed it in the United States.
The FDA has not reported any injuries or adverse events connected to the products involved in Blood Pressure Drug Recalls. The agency continues to monitor the situation and advises patients not to stop taking prescribed medication without first consulting a health care professional.
Rising Pharma and Inventia Healthcare have not publicly announced additional details regarding corrective actions beyond the recall notice.
Patients with questions about the recall are encouraged to contact their pharmacist, physician, or the distributor for guidance on replacement medication and next steps.
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