Macleods Pharma Withdraws Over 3,700 Blood Pressure Pill Bottles
The FDA classified the recall as Class II after finding that the combination tablets failed to dissolve at the required rates.
By Alessia Romano ·
3,744 bottles of a combination blood pressure medication were pulled from distribution across the United States. The products contained olmesartan medoxomil, amlodipine, and hydrochlorothiazide. Macleods Pharma USA Inc., a company based in New Jersey, initiated the withdrawal on October 7.
The U.S. Food and Drug Administration elevated the recall to a Class II status on October 26. This classification indicates that the tablets could cause temporary or medically reversible health problems. The agency assessed that the probability of serious health consequences remained low.
The specific defect involved the dissolution specifications of the drugs. The tablets did not break down or dissolve as required for proper absorption. The recalled inventory consisted of 3,528 bottles holding 30 units each and 216 bottles holding 90 units each.
The medication was available in doses of 40 mg, 10 mg, and 12.5 mg. The Mayo Clinic notes that this combination of drugs is prescribed to treat hypertension, commonly known as high blood pressure.
Telemundo Chicago reached out to Macleods Pharma for a comment regarding the quality failures. As of the publication of the report, the company had not issued a response.
The recall data confirms that the issues stemmed from non-compliant dissolution specs rather than contamination or mislabeling. The total number of affected bottles stands at exactly 3,744 units removed from circulation.
