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Cytosol Product Recall

All brands of Balanced Salt Solution (BSS) manufactured by Cytosol Laboratories, Inc. have been issued a Cytosol products recall request by the Food and Drug Administration (FDA).

The Cytosol products recall request came after reports that BSS products contained high levels of endotoxin, a substance found in bacteria that increase the risk of side effects including fever, shock, changes in blood pressure, and circulatory problems . In addition, Toxic Anterior Segment Syndrome (TASS), a serious and possibly irreversible eye injury, is linked to BSS drugs. The FDA also received Cytosol products-related injury complaints from more than 300 patients who had been given the product.

The FDA's Cytosol products recall issues immediate action by Cytosol Laboratories, Inc., hospitals, physicians, and consumers to stop taking the product and depose of all BSS inventory immediately. The three labels subject to the Cytosol products recall include:

  • AMO Endosol, distributed by Advanced Medical Optics, Inc.
  • Cytosol Ophthalmics, distributed by Cytosol Ophthalmics
  • Akorn, distributed by Akorn, Inc.

This February 2006 Cytosol products recall is not the first for the company. In 2000, Cytosol Laboratories, Inc. voluntarily recalled their product, TriCitrasol after an FDA issued warning. TriCitrasol was injected into patients during surgeries to keep bloodlines open and was reported to cause sudden death, fatal heart rhythm disruption, seizures, and bleeding.

If you or a loved one has suffered serious injuries from Cytosol products or to learn more about the Cytosol products recall, contact us today, FREE OF CHARGE, to speak with an experienced and qualified attorney who can help protect your legal interests.

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February 16, 2006 - FDA recalls Cytosol Laboratories Products

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