FDA Requests Recall of Contaminated Balanced Salt Solution Used During Surgery that Poses Serious Health Risks

In a letter delivered on Monday, February 13, the Food and Drug Administration (FDA) requested a recall of all brands and sizes of Balanced Salt Solution (BSS), manufactured by Cytosol Laboratories, Inc., of Braintree, Massachusetts.

BSS is a drug used to irrigate a patient’s eyes, ears, nose and/or throat during many surgical procedures including cataract surgery.

The recall is being requested because product some lots of the solution were found to have elevated levels of endotoxin.

Endotoxins, also known as pyrogens, are found in certain bacteria that cause a variety of severe reactions such as fever, shock, changes in blood pressure and in other circulatory functions.

The FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome(TASS). TASS occurs when a contaminant, such as endotoxin, enters the eye during surgery, causing an inflammatory reaction. 

The agency has also received reports of injuries in over 300 patients who were given BSS.

The FDA requests that the company immediately retrieve all inventories of BSS, including any existing stock at physicians’ offices and hospitals.

Hospitals, physicians, and consumers are being advised to stop using any of these products immediately, quarantine any remaining product, and destroy the product if no return instructions from Cytosol are received.

Roughly one million units of BSS products were distributed between December 2003 and December 2005. The BSS products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:

1. “AMO Endosol” distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.;

2. “Cytosol Ophthalmics” distributed by Cytosol Ophthalmics, Lenoir, NC; and

3. “Akorn” distributed by Akorn, Inc., Buffalo Grove, Ill.

For more information about the recall, individuals can call the FDA at 1-888-463-6332. Any adverse reactions or problems experienced with the use of this product should also be reported to the FDA MedWatch Program by completing a form online on the MedWatch web site at www.fda.gov/medwatch/report.htm, by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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