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Traditional ChineseSimplified ChineseText onlyPDARSS
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February 14, 2006
Recall
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Eye surgical solution recalled
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Cytosol Ophthalmics Balanced Salt Solution
Total recall: Consumers are advised not to buy or use Cytosol Ophthalmics Balanced Salt Solution which contains elevated levels of endotoxin, a substance that could be harmful.
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Consumers are advised not to buy or use Cytosol Ophthalmics Balanced Salt Solution which contains elevated levels of endotoxin, a substance that may have harmful effects.

 

The product, which is used to moisten a patient's eyes during a variety of surgical procedures, is manufactured by Cytosol Laboratories in the United States.

 

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.

 

The product is registered in Hong Kong with the registration number HK-42212. The importer has been instructed to recall the product. A total of 31,312 bottles of the product were distributed in local market over the last two years.

 

The bottles have been supplied to 25 institutions including Hospital Authority hospitals, private hospitals and clinics. All the hospitals/clinics have been informed of the recall.

 

Consumers are advised to stop using the product and to seek medical advice if they feel unwell. They should call the importer's hotline (6099 6858) for matters relating to the recall. For enquiries, call the Department of Health's hotline (2319 2839) during office hours.

 

Consumers should dispose of the product or submit the product to the department's Pharmaceutical Service at 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon.

 

The department has not received any report of serious adverse effects related to the use of this product. It urged medical professionals to report any serious adverse drug reaction.

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