New Jersey-based Macleods Pharma USA is recalling more than 3,700 bottles of a combination blood pressure tablet distributed nationwide. The pills failed dissolution specifications. The FDA classified the recall as Class II on Oct. 26, and the affected lots expire May 31, 2027.
A New Jersey-based drug company is recalling thousands of bottles of high blood pressure medication after they failed to meet federal quality standards. Macleods Pharma USA is recalling certain lots of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, according to the FDA. The bottles were manufactured by Macleods Pharma USA and distributed nationwide. More than 3,700 bottles have been recalled.
What is covered
The recall covers 3,528 30-count bottles and 216 90-count bottles of the 40 mg/10 mg/12.5 mg tablets. The 30-count bottles are from lot 12251163A, and the 90-count bottles are from lot 12251163B. The 30-count bottles carry NDC 33342-246-07, and the 90-count bottles carry NDC 33342-246-10. Both lots have an expiration date of 05/31/2027.
Reason for the recall
The FDA listed the reason as failed dissolution specifications, meaning the pills did not dissolve properly during testing. The drug may not release its active ingredients at a proper rate inside the body. Federal regulators described the voluntary recall as stemming from efficacy concerns. The tablets were recalled for failing a quality test.
Timeline and risk classification
Macleods Pharmaceuticals first recalled the tablets on Oct. 7. The FDA designated the recall Class II on Oct. 26. Under that class, use of the product may cause temporary or medically reversible adverse health consequences, but serious consequences are considered remote. For drugs, a Class II recall generally means consumers can keep using the medicine unless the company or FDA advises otherwise.
