Valeant Pharmaceuticals has recalled 3,341 bottles of Fenoglide tablets because the tablets failed 24 month dissolution tests.
Fenoglide, a peroxisome proliferator receptor alpha activator, is indicated to reduce cholesterol levels in patients at risk of cardiovascular disease. The company initiated the nationwide Class II recall on Sept. 9, according to an FDA enforcement report. The recall of the one lot of product is ongoing, the Canadian drugmaker says.
The Fenoglide (fenofibrate) 120 mg tablets in 90 count bottles were distributed by San Diego-based Santarus, a unit of Salix Pharmaceuticals. Valeant closed its $11.1 billion buyout of Salix on April 1.