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 are included in 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 while “a thorough review of the global post-marketing safety database has not revealed evidence of a signal suggesting reduced efficacy,” it “cannot definitively exclude this possibility.” The company said there is a “potential for an impact on the anticipated blood pressure lowering efficacy.”
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, according to the company.
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