FDA REQUESTS RECALL OF BSS PRODUCT

The FDA has sent a letter to Cytosol Laboratories, requesting the firm recall all brands and sizes of its Balanced Salt Solution (BSS) drug because of dangerous levels of endotoxin.

BSS is used to irrigate a patient's eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery, the agency said recently.

The FDA requested the recall because product lots were found to have elevated levels of endotoxin -- a substance found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions. The FDA said it has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome (TASS), which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction.

The FDA requests that the company take immediate action to retrieve all inventories of the product, including any existing stock at physician offices and hospitals.