Manufacturer recalls 60 million tablets of blood pressure medication

October 19, 2010

Bristol-Myers Squibb Co. recalled 60 million tablets of the blood pressure medication Avalide (irbesartan-hydrochlorothiazide) in the United States and Puerto Rico.

Bristol-Myers Squibb Co. recalled 60 million tablets of the blood pressure medication Avalide (irbesartan-hydrochlorothiazide) in the United States and Puerto Rico.

According to the company, 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, irbesartan, which could result in slower dissolution. The recalled tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

Sixty-two lots, or 60 million tablets, manufactured before November 2009 at its Puerto Rico plant were affected by the recall.

In a statement, the company said that “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.”

“Other than the potential for an impact on the anticipated blood-pressure-lowering efficacy, we are not aware of any other risk to patients who may have taken product from these lots,” added company spokeswoman Christina Trank.

Other lots of Avalide 300/25 mg, as well as other dosage strengths of both Avalide and Avapro, or irbesartan, are not affected, and no interruption in supply is anticipated, the company said.