Recall of unregistered pharmaceutical product
26 Apr 2011
The Department of Health (DH) today (April 26) instructed Nidoway Investment Ltd (Nidoway), a holder of certificate of drug/product registration, to recall from consumers one of its items on sale called "Supirocin Ointment 2% 10g" for two reasons.
Firstly, the item has yet to be registered as a pharmaceutical product; and two, discrepancy has been found between the labelled and actual active ingredient contents.
A DH spokesman acknowledged that while Nidoway is applying to the Pharmacy and Poisons Board for the further introduction of the 10g pack size in addition to other approved pack sizes, namely 5g, 15g and 50g, the application is still under scrutiny.
The spokesman explained that the illegal sale came to DH's notice when during routine market surveillance, analysis on 10g samples purchased revealed that only 0.25% instead of 2% of the active ingredient mupirocin was identified.
Further investigation detected that in fact a total of 4 516 tubes of 10g packs of "Supirocin Ointment 2%" had been imported by Nidoway from Macau and being supplied to G & L Medical (USA) Co Ltd (G & L), a licensed drug wholesaler, for sale to pharmacies in Hong Kong.
"Supirocin Ointment 2%", manufactured in India, is a topical antibiotic for the treatment of bacterial skin infection. It requires doctors' prescription and can only be sold in pharmacies, under the supervision of pharmacists.
While DH's investigation will continue, especially targeting at the preparations of other volumes, the DH spokesman advised healthcare professionals and retailers to stop supplying the said product to their clients. The lowered active ingredient content may lead to ineffective treatment and contribute to antibiotic resistance. People who have used the affected product should consult healthcare providers if in doubt or feel unwell.
"Here, contravention of Cap 132, selling drug not of the nature, substance or quality demanded by the purchaser and Cap 138, selling unregistered drug might have occurred. The maximum penalties involved are $10,000 and 3 months imprisonment and $100,000 and 2 years imprisonment respectively ," the spokesman remarked.
It is noted that Nidoway has set up a hotline 2574 4482 to answer related enquiries during office hours.