Press Release

DH instructs importer to recall unregistered artificial tears

4 Apr 2009

The Department of Health (DH) today (April 4) instructed Novartis Pharmaceuticals (HK) Ltd (Novartis), a licensed drug supplier, to recall a brand of artificial tears called Viscotears from the market as the product was found to be a pharmaceutical product without registration in Hong Kong.

Viscotears is manufactured in Germany and registered in some countries of the European Union. The product is used for easing dry eye syndrome.

A DH spokesman said the case was reported by the United Christian Hospital yesterday after the latter queried during a current drug stock-taking exercise if the product concerned should be registered.

DH initiated an investigation and inspected the offices of Novartis and Zuellig Pharma Limited (a licensed drug wholesaler which imported Viscotears for Novartis) yesterday evening.

According to available analysis reports obtained from the importer, there is no immediate safety, efficacy or quality concern with the consumption of the product. However, doctors and pharmacists are reminded to stop administering it to their clients as the product is an un-registered drug in Hong Kong.

The spokesman said Viscotears were distributed to 17 public hospitals, some private hospitals, private doctors, pharmacies, drug stores and vet clinics.

DH has instructed the company to recall the products from the market.

The company has set up a hotline (2881 4259) to answer clients' enquiries from 9 am to 5 pm daily.

DH has also set up a hotline (2319-2905) for enquiries. The hotline will operate up to 9 pm today and from 9 am to 5 pm tomorrow onward.

DH's investigation is ongoing.

The spokesman said sale of unregistered pharmaceutical product was an offence under the Pharmacy and Poison Ordinance. Upon conviction, the maximum penalty is a fine of HK$100,000 and 2 years' imprisonment.