Macleods Pharma USA launched a blood pressure medication recall after certain lots of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets failed dissolution testing and were distributed nationwide. The action covers 3,528 30-count bottles and 216 90-count bottles.
The recalled 30-count bottles came from lot 12251163A, and the 90-count bottles came from lot 12251163B. Both lots expire May 31, 2027, and the bottles carry NDC 33342-246-07 and NDC 33342-246-10.
Macleods Pharma USA And FDA
Macleods Pharma USA initiated the recall on Oct. 7. The FDA later classified it as a Class II recall on Oct. 26, putting the case in the category the agency uses when use may cause temporary or medically reversible adverse health consequences.
The recall remains ongoing, and the affected tablets were sold nationwide as a prescription drug used for high blood pressure. Patients who have the product can check the lot numbers and National Drug Codes on their bottles against the recalled lots.
Failed Dissolution Specifications
The FDA listed failed dissolution specifications as the reason for the recall. Dissolution testing measures how a tablet breaks down and releases its ingredients; when a product fails that standard, the concern is that it may not perform as intended once swallowed.
That complication is part of what makes this recall notable. The tablets failed a federal quality test, yet the FDA still placed the action in Class II rather than the most serious recall category.
Inventia Healthcare Ltd. Comparison
The case follows a September recall by Inventia Healthcare Ltd. of 13,567 bottles of 25-milligram chlorthalidone tablets after that medication also failed dissolution testing. For patients using this type of blood pressure treatment, the practical step is the same: check the bottle's lot number and NDC before taking more tablets from the same package.
What remains most important for a patient holding one of these bottles is the label information, not the size of the supply. A 30-count bottle from lot 12251163A or a 90-count bottle from lot 12251163B falls inside the recall, and both were part of the nationwide distribution already on the market.
