20 Apr 2009
In response to media enquiries on the recall of Mentholatum pain patch by Mentholatum (Asia Pacific) Ltd. at retail level, a spokesman for the Department of Health (DH) today (April 20) said the pharmaceutical product concerned had yet to be registered by DH.
The spokesman said the company had applied for registration of the product in 2005. The product was manufactured in Taiwan. During the process of assessment, DH found that the safety and quality of the drug had met the registration requirements. However, the company has yet to provide sufficient information on the efficacy of the product to facilitate registration.
As the product was found on sale in local market before registration was approved, the company was instructed to recall it at retail level earlier this month, the spokesman said.
Although the safety of the drug was not an issue of concern, people should stop using the product and seek advice from doctors or pharmacists as appropriate on the use of alternative drugs, the spokesman said.
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.