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U.S. Department of Health and Human Services

Safety

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Cytosol Laboratories, Inc. Balanced Salt Solution (BSS)

Audience: Ophthalmologists, operating room supervisory staff and other healthcare professionals
[Posted 02/14/2006] FDA notified healthcare professionals and patients of the request for recall of all brands and sizes of Balanced Salt Solution (BSS) manufactured by Cytosol Laboratories, Inc. because product lots were found to have elevated and dangerous levels of endotoxin. BSS is a drug used by health professionals to irrigate a patient’s eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery. FDA 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.  FDA has also received complaints relating to injuries in over 300 patients who were given BSS manufactured by Cytosol Laboratories The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:

"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.

[February 13, 2006 – News Release – FDA]