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3,744 blood pressure pills pulled from US markets

New Jersey firm Macleods Pharma USA Inc. ordered the withdrawal of specific olmesartan tablets that failed to dissolve correctly.

By Kenji Garnier ·

Illustration for: 3,744 blood pressure pills pulled from US markets
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Macleods Pharma USA Inc. removed 3,744 bottles of blood pressure medication from the market in the United States because the tablets failed to dissolve as required. The company, based in New Jersey, issued the recall order on October 7. The Food and Drug Administration classified the action as a Class II recall on October 26. This designation indicates the drugs could cause temporary health issues or medically reversible problems, though the risk of serious harm is considered low.

The affected product combines olmesartan medoxomil, amlodipine, and hydrochlorothiazide. These ingredients are prescribed to treat hypertension. The specific failure cited in the report is "non-compliant dissolution specifications." This means the pills did not break down in the body as intended during testing.

The recall covers two dosage strengths: 40 mg, 10 mg, and 12.5 mg. The medication was packaged in bottles containing either 30 or 90 units. Macleods Pharma removed 3,528 bottles of the 30-unit size and 216 bottles of the 90-unit size from distribution channels.

The company had not responded to inquiries from Telemundo Chicago prior to the publication of the report. The recall notice was distributed nationally. Patients are advised to check their medicine cabinets for the specific combination of ingredients and dosage strengths listed in the FDA report.

The timeline for the recall began with the initial order on October 7. The FDA formally assigned the Class II status on October 26. The total count of 3,744 bottles represents the sum of the two packaging sizes withdrawn from the supply chain.

Source: KVDA

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