FDA recalls Cytosol balanced salt solution

WASHINGTON — The Food and Drug Administration has requested that Cytosol Laboratories recall any and all brands and sizes of balanced salt solution that the company manufactures. A letter requesting the recall was delivered to Cytosol on Feb. 13, according to information posted on the FDA Web site.

The FDA initiated the recall after finding that product lots had elevated levels of endotoxin, a substance found in certain bacteria that can cause severe reactions including fever, shock, and changes in blood pressure and other circulatory functions, according to the statement on the FDA’s Web site.

“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,” the statement says. In addition, the FDA is asking hospitals, physicians and consumers to stop using any balanced salt solution products from Cytosol immediately and to quarantine the remaining product. If no instructions for returning the product are received from Cytosol, the product should be destroyed, the notice says.

The Cytosol Labs products subject to the recall were distributed under three labels: AMO Endosol (Advanced Medical Optics), Cytosol Ophthalmics (Cytosol) and Akorn (Akorn).

AMO issued a voluntary recall of its Endosol product on Nov. 18, 2005, after receiving reports of toxic anterior segment syndrome (TASS), a serious and sometimes irreversible noninfectious inflammation of the eye.

However, at the time Cytosol continued to ship the product and claimed it had confirmed the product safety.

In addition to reports of TASS, the FDA said it has received complaints related to injuries in more than 300 patients who received balanced salt solution manufactured by Cytosol.

The FDA statement said an estimated that 1 million units of BSS products were distributed over a 2-year span from December 2003 to December 2005.