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Total recall of "Cyclovax Cream 5%" (with photo)
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     Further to mandatory recall from consumers of a batch (lot number: 44254) of "Cyclovax Cream 5%" (registration number: HK-43836) required by the Department of Health (DH) on May 4 because of quality defect, the Department again instructs Healthcare Pharmascience Ltd (Pharmascience), a pharmaceutical product registration certificate holder, to recall all of its "Cyclovax Cream 5%" from consumers today (May 12) as ongoing investigation by DH revealed that the quality defect involves more batches.

     A DH spokesman elaborates that further analysis by the Government Laboratory on samples of another batch (lot number: 46834) of "Cyclovax Cream 5%" which DH has submitted for testing on May 4 reveals that only 3.5% of the active ingredient aciclovir was identified instead of 5% as labelled.

     Tracking by DH has shown that "Cyclovax Cream 5%" was manufactured by Remedica Limited in Cyprus.  It was then imported by Pharmascience into Hong Kong for supply to pharmacies, private doctors and also for export to Macao.

     "Cyclovax Cream 5%" is a topical antiviral drug for the treatment of herpes simplex virus skin infection.  It has to be prescribed by doctors and can only be sold in dispensaries, under the supervision of pharmacists.

     The spokesman remarks that substandard quality of the drug may result in ineffective treatment of the skin infection.  In the circumstances, there could be a possible contravention of Hong Kong Law Cap 132, the Public Health and Municipal Services Ordinance, selling drug not of the nature, substance or quality demanded by the purchaser.  

     "Healthcare professionals and retailers must stop supplying all batches of the said product.  For people who have used the affected product and are either in doubt or if feel unwell, they ought to consult their healthcare providers.  DH will refer the incident for the Department of Justice's advice.  The maximum penalty can be up to HK$10,000 and three months imprisonment," the spokesman said.

     Pharmascience has already set up a hotline 2565 6309 since May 4 for handling related enquiries.

     DH will continue to monitor the recall closely and will also investigate into all other pharmaceutical products from the same Cyprus manufacturer which have been registered with the Pharmacy and Poisons Board.  

     Meanwhile, DH has also informed the drug authority in Cyprus of the findings for their necessary follow-up.

Ends/Thursday, May 12, 2011
Issued at HKT 20:32

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