*A prescription combination pill for high blood pressure is being recalled across the U.S. after lab testing showed the tablets were not breaking down properly.
Macleods Pharma USA, a drugmaker based in New Jersey, is recalling two lots of its Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets. The U.S. Food and Drug Administration cited “failed dissolution specifications” as the reason, Fox Business reports. That means the medication did not dissolve as expected during quality testing.
The recall affects only those two lots, not every bottle of the medication on the market. The FDA has classified the recall as Class II, meaning the affected products “may cause temporary or medically reversible adverse health consequences.” The agency considers serious harm unlikely.
The company initiated the recall on Oct. 7, and the FDA assigned its classification on Oct. 26. The recall remains active, with affected bottles distributed nationwide.
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In total, 3,744 bottles are involved. That includes 3,528 bottles containing 30 tablets each, from lot 12251163A. Another 216 bottles containing 90 tablets each come from lot 12251163B. Both lots expire 31, 2027.
Patients can check whether their medication is affected by looking at the bottle’s label. Along with the lot number, each bottle lists a National Drug Code, or NDC. The 30-tablet bottles show NDC 33342-246-07, while the 90-tablet bottles show NDC 33342-246-10.
Anyone unsure whether their medication is affected can compare the lot number and NDC on their bottle with the recall details above. A pharmacist or doctor can confirm whether a bottle is part of the recall and discuss replacement options. In the meantime, patients should not stop taking their blood pressure medication without medical advice.
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