Hong Kong Based Novartis Recalls Un-Registered Eye Ointment
The Hong Kong Department of Health instructed Novartis Pharmaceuticals (HK) Ltd (Novartis), a licensed drug supplier, to recall a batch of eye ointment called Cortiphenol H Eye ointment 2.5 g (batch no. 414733) from the market as the product was found to be a pharmaceutical product the registration of which was expired in December 2007.
The product is manufactured in Switzerland and is used for eye inflammation.
A DH spokesman said the product was registered in Hong Kong between 1987 and 2007. (Registration no. HK-29800). Registration of pharmaceutical products must be renewed every five years should they still be put on sale in local market. But the importer did not apply for renewal of the registration of the eye ointment concerned after December 2007.
During recent investigation into the sale of un-registered eye drops by Novartis, DH found that about 10,000 tubes of the product had been supplied to private hospitals, private doctors and pharmacies after December 2007.
Although the tubes involved were imported in November 2007, they were classified as un-registered pharmaceutical products as the importer did not comply with the registration requirements.
The spokesman said there was no immediate safety, efficacy or quality concern with the use 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.
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. DH has also set up a hotline (2319 2905) for enquiries. The hotline will operate from 9am to 5pm on weekdays. 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 two years' imprisonment.