Thousands of bottles of a prescription blood-pressure medicine have been recalled across the United States after the tablets failed a quality test, the US Food and Drug Administration (FDA) said.
Macleods Pharma USA is recalling specific lots of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, a combination treatment used to manage high blood pressure.
The recall covers 3,528 bottles containing 30 tablets from lot 12251163A and 216 bottles containing 90 tablets from lot 12251163B — 3,744 bottles in total. Both lots have an expiry date of 31 May 2027.
Patients can check their medicine packaging for the lot number and National Drug Code. The affected 30-tablet bottles carry NDC 33342-246-07, while the 90-tablet bottles carry NDC 33342-246-10.
Why has the blood pressure medicine been recalled?
The FDA said the tablets failed to meet “dissolution specifications”. The test measures whether a medicine dissolves at the required rate so that its ingredients can be released properly in the body.
The agency has classified the action as a Class II recall. That means use of the affected product could cause temporary or medically reversible health problems, although the risk of serious harm is considered remote.
Macleods Pharma USA began the recall on 7 October, and the FDA classified it on 26 October. The recall remains active and applies to products distributed nationwide.
Patients who believe they may have an affected bottle should check the lot and NDC details and speak to a pharmacist or doctor before making any change to their treatment. They should not stop taking prescribed blood-pressure medicine without medical advice.
