Contact A Lawyer
Near You

Contact us today for a complimentary consultation with a qualified attorney near you.

FDA recalls Cytosol Laboratories Products

February 16, 2006

Today, the FDA announced the recall of all brands and sizes of Balanced Salt Solution (BSS) products made by Cytosol Laboratories. This Cytosol products recall was issued because these products contain dangerous levels of endotoxins. Balanced Salt Solutions is a drug used to irrigate the eyes, ears, nose, and/or throat during a variety of surgical procedures, including cataracts surgery.

Dangers of Cytosol products

The FDA issued the recall because these products were contaminated with endotoxin. Also known as pryogens, endotoxins, are found in certain bacteria that can cause serious side effects including:

  • Fever
  • Shock
  • Changes in blood pressure
  • Circulatory problems
  • Toxic Anterior Segment Syndrome (TASS)

Toxic Anterior Segment Syndrome

TASS is an irreversible eye injury that occurs when a contaminant like endotoxin enters the anterior area of the eye during surgery. This contaminant produces an inflammatory response in the affected eyes.

The FDA has also received an additional 300 injury complaints form patients who were administered Balanced Salt Solution Cytosol products.

The FDA's Cytosol recall

The FDA announced that all hospitals, physicians, and consumers stop using Balanced Salt Solution Cytosol products immediately, quarantine remaining products, and destroy those products if no instructions have been received from Cytosol. The FDA has also stated that Cytosol must take immediate action to receive all Balanced Salt Solution products, including those in stock at hospitals and doctor's offices. Any person who has experienced Cytosol product side effects is urged to contact the FDA, via their MedWatch program immediately.

The Damage

At least one million units of defective Cytosol products have been used or distributed since December 2003. The Cytosol recall affects all BSS products manufactured under these labels:

  • "Akorn" distributed by Akorn, Inc. in Buffalo Grove, Illinois
  • "Cytosol Ophthalmics" by Cytosol Ophthalmics in Lenoir, North Carolina
  • "AMO Endosol" by Advanced Medical Optics, Inc. in Santa Ana, California

If you or a loved one has been injured after receiving Balanced Salt Solution Cytosol products, please contact us to learn more about your legal rights. You may be eligible to seek compensation for your losses and suffering.

For more information on drug safety information, please contact us to confer with an attorney.

More Recent Defective Drug News

Contact a News Recall Lawyer