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February 13: FDA-Requested Recall - Cytosol Laboratories, Inc. Product Contains Dangerous Levels of Endotoxin

The U.S. Food and Drug Administration (FDA) today delivered a letter to Cytosol Laboratories, Inc., of Braintree, Mass., to request a recall of all brands and sizes of Balanced Salt Solution (BSS) that the firm manufactures. 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 requested the recall because product lots were found to have elevated levels of Endotoxin. Endotoxin, also known as pyrogens, are substances 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. 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, Inc.

FDA had asked the company to take immediate action.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/bbs/topics/news/2006/NEW01315.html
http://www.eyeworld.org/ewweek.php?id=394&query=amo recall#2

If you have any comments regarding this update, please email: info@mdiconsultants.com

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