Over 3,700 Blood Pressure Pill Bottles Pulled After Dissolution Failures
Macleods Pharma USA ordered the withdrawal of 3,744 bottles on October 7 after testing showed the tablets did not break down as required.
By Thabo Hoffmann ·
A total of 3,744 bottles of a triple-drug blood pressure medication were removed from the market in the United States following a quality failure. The U.S. Food and Drug Administration identified the issue, which affected a widely distributed prescription used to treat hypertension.
Macleods Pharma USA Inc., a company based in New Jersey, initiated the recall on October 7. The products involved combine olmesartan medoxomil, amlodipine, and hydrochlorothiazide. On October 26, the agency classified the action as a Class II recall. This designation indicates that the pills could cause temporary or medically reversible health problems, though the risk of serious injury remains low.
The specific defect involved the tablets failing to meet dissolution specifications. In plain terms, the pills did not break apart or dissolve in the body as intended by their design. The medication was sold in two container sizes containing 30 and 90 tablets each. The doses available were 40 mg, 10 mg, and 12.5 mg.
Of the 3,744 bottles removed, 3,528 contained 30 tablets and 216 contained 90 tablets. Telemundo Chicago contacted Macleods Pharma for comment regarding the specific batches and distribution details. As of the publication of the report, the company had not responded to the inquiry.
Patients using these prescriptions are advised to check their pill bottles against the specific lot numbers listed in the FDA report. The medication is commonly prescribed for high blood pressure, a condition that affects a large portion of the adult population.
