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Recall of Cytosol Ophthalmics Balanced Salt Solution

  • 2006.02.14

"Cytosol Ophthalmics" Balanced Salt SolutionThe Department of Health (DH) today (February 14) instructed the recall of "Cytosol Ophthalmics" Balanced Salt Solution, a pharmaceutical product used to to irrigate a patient's eyes during a variety of surgical procedures.

The product was found to contain elevated levels of endotoxin, a substance that may cause harmful effect.

Members of the public are advised to stop using the product manufactured by Cytosol Laboratories, Inc. in the United States and consult their doctors if they feel unwell.

A DH spokesman said, "The recall was made following a similar order made by the U.S. Food and Drug Administration (FDA)."

Endotoxins, also known as pyrogens, are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure and in other circulatory functions. U.S. FDA has received reports of a serious eye injury which occurs when a contaminant, such as endotoxin, enters the eye during surgery. 

The product is registered in Hong Kong with registration number HK-42212. A total of five pack sizes are registered. They are 18 ml plastic bottle, 250 ml plastic bottle, 500ml plastic bottle, 200ml glass bottle and 500ml glass bottle.

The importer was instructed to recall all sizes of the product. According to the importer, a total of 31 312 bottles of the product were distributed to local market in the last two years, the spokesman said.

The bottles have been supplied to 25 institutions including Hospital Authority hospitals, private hospitals and clinics. The importer had notified all the hospitals/clinics about the recall and remaining stock of the product should be returned to the importer in due course.

"Members of the public are advised to dispose of the product or to submit the product to the Pharmaceutical Service of DH at 3/F., Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon. DH has also set up a hotline 2319 2839 for enquiries during office hours," the spokesman said. Members of the public may also call the importer's telephone number 6099 6858 for enquiry.

"DH has not received any report of serious adverse events related to the use of this product. It will closely monitor the situation.

"Medical professionals are urged to report any observed serious adverse drug reaction to DH," he added.

Reprinted from HKSAR Government web page: