This is the second Avalide recall, the first was in September 2010. The September recall involved 62 lots or 60 million tablets. Both recalls involve product manufactured in plants in Puerto Rico and the United States. The new recall involves 65 lots of Avalide manufactured in plants in Humacal, Puerto Rico and Evansville, Indiana, the company said.
Avalide combines the drugs irbesartan, which is sold under the brand name Avapro, and hydrochlorothiazide, a generic diuretic.
According to a report on Reuters, BMS did not announce the recall publicly, but instead notified wholesalers and healthcare professionals via letters. The recall has been issued as a precautionary measure. Bristol-Myers spokeswoman Christina Trank told Reuters that the company has not turned up evidence of reduced effectiveness, nor have there been any reports of safety problems or patient harm. Avalide is co-marketed with Sanofi-Aventis.