The blood pressure medication <"http://www.yourlawyer.com/practice_areas/defective_drugs">Avalide is being recalled in the US and Puerto Rico, Bristol-Myers Squibb announced today. The company said the recall involves 62 lots, or 60 million tablets, manufactured before November 2009 at its plant in Puerto Rico.
The recall was issued 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, a company statement 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,” the statement said.
“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,” a spokesperson for Bristol-Myers Squibb told Reuters.
Avalide is comprised of the drugs irbesartan and hydrochlorothiazide. The recalled tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Other lots of Avalide 300/25 mg, as well as other dosage strengths of both Avalide and Avapro, or irbesartan, are not affected, the company said.