Quoted from http://www.reuters.com/article/idUSTRE68S3KF20100929
Bristol-Myers recalls blood pressure drug Avalide
By Debra Sherman
CHICAGO | Wed Sep 29, 2010 1:20pm EDT
CHICAGO (Reuters) - Bristol-Myers Squibb Co is recalling 60 million tablets of the blood pressure medication Avalide in the United States and Puerto Rico.
The company said it took the action on behalf of the Bristol-Myers Squibb/Sanofi-Synthelabo partnership because of a potential variability in levels of the less-soluble form of the active ingredient in Avalide, irbesartan, which could result in slower dissolution.
Bristol-Myers said 62 lots, or 60 million tablets, manufactured before November 2009 at its plant in Puerto Rico were affected by the recall.
Avalide is comprised of the drugs irbesartan and hydrochlorothiazide. The recalled tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
In a statement, the company said "a thorough review of the global post-marketing safety database has not revealed evidence of a signal suggesting reduced efficacy. However we cannot definitively exclude this possibility."