Feb. 14, 2006 – The US Food and Drug Administration (FDA) has requested the recall of all brands and sizes of balanced salt solution (made by Cytosol Laboratories, Inc), due to the presence of elevated endotoxin levels in some lots.
The action was based on more than 300 reports of injuries, including toxic anterior segment syndrome, in patients receiving the products, according to an alert sent today from MedWatch, the FDA’s safety information and adverse event reporting program.
According to the FDA, the manufacturer has been asked to take immediate action to retrieve all inventories of the product, including existing stock at physician offices and hospitals.
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