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News · Orlando

Over 3,700 Blood Pressure Bottles Pulled From Shelves

FDA records show Macleods Pharma USA ordered a Class II recall on October 7 after tablets failed to dissolve properly.

By Nia Foster ·

Illustration for: Over 3,700 Blood Pressure Bottles Pulled From Shelves
Illustration generated for this article, not a news photograph.

3,744 bottles of blood pressure medication were removed from circulation across the United States this month. The FDA reported that the pills failed to break down or dissolve as required by quality standards.

Macleods Pharma USA Inc., a New Jersey-based company, initiated the recall on October 7. The agency classified the action as Class II on October 26. This ranking indicates the products could cause temporary health problems or issues that are medically reversible. Officials stated the likelihood of serious health consequences is low.

The recalled items contained three active ingredients: olmesartan medoxomil, amlodipine, and hydrochlorothiazide. The medication comes in doses of 40 mg, 10 mg, and 12.5 mg. Bottles were sold in packs of 30 or 90 tablets. The recall covered 3,528 bottles of 30 tablets and 216 bottles of 90 tablets.

The FDA cited unmet dissolution specifications as the reason for the pull. The Mayo Clinic notes that these specific prescriptions are used to treat high blood pressure, also known as hypertension.

Telemundo Chicago reached out to Macleods Pharma for a response. The company had not replied by the time the report was published.

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