The FDA sent Cytosol Laboratories Inc. a letter requesting the recall of all brands and sizes of its balanced salt solution (BSS). The FDA also instructed hospitals, physicians, and consumers to stop using the product immediately and quarantine any remaining product. If no return instructions from Cytosol are received, users are urged to destroy the product.
The letter was initiated because product lots had elevated levels of endotoxin, according to the FDA. Found in certain bacteria, endotoxin can cause serious reactions such as fever, shock, and changes in blood pressure and other circulatory functions. The FDA received reports of toxic anterior segment syndrome as well as complaints relating to injuries in more than 300 patients who were treated with Cytosol's BSS.
An estimated 1 million units were distributed between December 2003 and December 2005 under the following labels:
Akorn, distributed by Akorn Inc., Buffalo Grove, IL
AMO Endosol, distributed by Advanced Medical Optics Inc., Santa Ana, CA
Cytosol Ophthalmics, distributed by Cytosol Ophthalmics, Lenoir, NC
Any adverse reactions or problems after use of BSS should be reported to the FDA MedWatch Program by completing a form online, www.fda.gov/medwatch/report.htm ; by phone, 800/FDA-1088; by fax, 800/FDA-0178; or by mail, MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.