Macleods Pharma Recalls 3,744 Blood Pressure Pill Bottles
FDA classifies the withdrawal as Class II due to tablets failing to dissolve properly.
By Renata Mehta ·
Macleods Pharma USA Inc. pulled more than 3,700 bottles of blood pressure medication from national distribution after testing revealed the pills did not break down correctly. The New Jersey-based company ordered the recall of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets on October 7.
The U.S. Food and Drug Administration classified the withdrawal as a Class II recall on October 26. This designation indicates the medication could cause temporary or medically reversible health problems. The agency assessed the likelihood of serious health consequences as low.
The defective drugs were sold in bottles containing either 30 or 90 units. Each tablet contained a dose of 40 mg, 10 mg, or 12.5 mg. A total of 3,528 bottles of 30 units were removed from circulation. An additional 216 bottles of 90 units were also recalled.
The FDA report cited unmet dissolution specifications as the reason for the action. This means the tablets failed to dissolve at the rates required for proper absorption. Mayo Clinic notes that these specific prescriptions are used to treat high blood pressure.
Macleods Pharma did not respond to requests for comment from Telemundo Chicago before the report was published. The company remains the manufacturer of the affected products.
Source: KVDA
