FDA pulls 3,744 blood pressure pill bottles over quality failure
Macleods Pharma USA voluntarily recalled 3,528 thirty-unit bottles and 216 ninety-unit bottles after tablets failed to dissolve properly.
By Neha Delgado ·
More than 3,700 bottles of a combination blood pressure medication were pulled from the market because the tablets did not break down or dissolve as required.
The Food and Drug Administration reported that 3,528 thirty-unit bottles and 216 ninety-unit bottles were removed from circulation. The recalled pills contained olmesartan medoxomil, amlodipine, and hydrochlorothiazide in doses of 40 mg, 10 mg, and 12.5 mg.
Macleods Pharma USA Inc., based in New Jersey, initiated the recall on October 7. On October 26, the agency classified the action as a Class II recall. This classification indicates that the medication could cause temporary or medically reversible health problems, though the likelihood of serious harm is considered low.
The recall stems from non-compliance with dissolution specifications. The tablets failed to meet the standards for how quickly they should dissolve in the body. According to the Mayo Clinic, such prescription drugs are used to treat hypertension, or high blood pressure.
The company has not yet responded to requests for comment from Telemundo Chicago. The FDA report confirms the specific quantities removed from the national supply chain.
Source: WTMO-CD
