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News · Dallas

FDA recalls thousands of blood pressure pills that fail to dissolve

Macleods Pharma removed 3,744 bottles of triple-drug tablets from national distribution after quality tests showed they do not break down as required.

By Robert Ward ·

Illustration for: FDA recalls thousands of blood pressure pills that fail to dissolve
Illustration generated for this article, not a news photograph.

The U.S. Food and Drug Administration has confirmed the withdrawal of more than 3,700 bottles of a popular blood pressure medication from national distribution. The agency classed the recall as Class II on October 26, indicating that the tablets could cause temporary or medically reversible health issues, though the likelihood of serious harm remains low.

Macleods Pharma USA Inc., based in New Jersey, initiated the recall on October 7. The company removed tablets containing olmesartan medoxomil, amlodipine, and hydrochlorothiazide. These prescription drugs are commonly prescribed to manage high blood pressure, or hypertension.

The specific defect involves the tablets failing to meet dissolution specifications. According to the FDA report, the pills did not disintegrate or dissolve in the body as required. This failure in the breakdown process can affect how the medication is absorbed, potentially altering its therapeutic effect for patients.

The recalled inventory consisted of 3,528 bottles containing 30 units each and 216 bottles with 90 units each. The tablets were available in a combined dosage of 40 mg, 10 mg, and 12.5 mg. Macleods Pharma did not provide a response to inquiries from news outlets by the time the initial report was published.

Health officials advise patients to check their home medicine cabinets for these specific bottles. The recall affects products distributed across the United States. The company has not yet announced whether it will issue refunds or replacements for the affected inventory.

Source: KXTX-TV

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