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Cytosol Product

The Food and Drug Administration requested a recall of all Cytosol products that are Balanced Salt Solution (BSS). The FDA issued the recall in February 2006 after reports indicated that BSS, a drug used by medical professionals to moisten eyes, ears, nose, and throat during surgical procedures, had high levels of endotoxin. Endotoxins are found in bacteria that may cause a wide range of severe reactions including:

  • Shock
  • Fever
  • Changes in blood pressure
  • Circulatory problems

Other reports of Toxic Anterior Segment Syndrome (TASS) -a serious and possibly irreversible eye injury that occurs when bacteria gets into the eye and caused inflammatory reactions-have raised additional concerns over the BSS Cytosol products. Furthermore, the FDA received more than 300 BSS Cytosol product injury complaints.

The FDA asked BSS manufacturer, Cytosol Laboratories, Inc. of Braintree, Mass., to immediately stop distribution and retrieve all inventories of the BSS Cytosol products. In addition, the FDA urgently requests that all hospitals, physicians, and consumers stop the use of the BSS Cytosol products and destroy any remaining units.

Approximately one million BSS Cytosol products were distributed between December 2003 and December 2005, putting many surgical patients at an increased risk for serious and dangerous side effects caused by a BSS Cytosol product.

The Cytosol product recalls issued by the FDA include the following drug names and brands, all manufactured by Cytosol Laboratories, Inc:

  • AMO Endosol, distributed by Advanced Medical Optics, Inc. (AMO), Calif.
  • Cytosol Ophthalmics, distributed by Cytosol Ophthalmics, NC
  • Akorn, distributed by Akorn, Inc. Ill.

This is the not the first time a Cytosol product has been recalled. In 2000, Cytosol Laboratories, Inc. voluntarily recalled their product, TriCitrasol, after an urgent FDA warning. TriCitrasol, used to keep bloodlines open during surgery, was reported to cause severe side effects including fatal hearth rhythm disruption, seizures, and even death.

If you or a loved one has suffered serious injury from a Cytosol product or to learn more information about Cytosol products, contact us today to speak with an experienced and qualified attorney who can help protect your legal rights and interests.

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