Blood Pressure Medication Recalled After Quality Test Failure
Macleods Pharma USA is recalling two lots of a prescription blood pressure medication distributed nationwide after the tablets failed a quality test, according to the U.S. Food and Drug Administration. The affected product contains olmesartan medoxomil, amlodipine and hydrochlorothiazide. The recall remains ongoing.
The recall covers 3,528 bottles containing 30 tablets from lot 12251163A and 216 bottles containing 90 tablets from lot 12251163B. Both lots expire May 31, 2027. The National Drug Code, or NDC, is 33342-246-07 for the 30-count bottles and 33342-246-10 for the 90-count bottles. Consumers can compare those numbers with the information on their prescription bottles to determine whether they have an affected product.
The FDA listed “failed dissolution specifications” as the reason for the recall. That means the tablets did not dissolve as required during testing. The agency classified the action as a Class II recall, a category in which use of the affected medication may cause temporary or medically reversible adverse health consequences, but serious consequences are considered unlikely.
Macleods Pharma USA initiated the recall on Oct. 7, and the FDA classified it on Oct. 26. The report did not state whether any patients had experienced adverse effects. FOX Business said it could not immediately reach the company for comment.
The action follows a separate recall of another blood pressure medication. In September, India-based Inventia Healthcare Ltd. recalled 13,567 bottles of 25-milligram chlorthalidone tablets after that medication also failed dissolution testing, according to the FDA. Chlorthalidone is used to treat high blood pressure and fluid retention.
The recalls involve different manufacturers and medicines, though both resulted from dissolution test failures. For people checking their medication, the Macleods recall identifies the affected bottles by lot number, bottle size and NDC. Its stated scope is limited to the two listed lots of the combination tablets.