Press Release
Recall of Uni-Betasone 0.1% Cream
7 Feb 2012
The Department of Health (DH) today (February 7) instructs a licensed drug manufacturer, Universal Pharmaceutical Laboratories Limited (Universal), to recall from shelf all batches of Uni-Betasone 0.1% Cream (registration number: HK-58723) because of suspected quality defect.
A DH spokesman elaborates that “During DH's routine inspection of Universal, a sample of the above is drawn for end product analysis. Subsequently, the Government Laboratory finds it to contain 1.2mg/g betamethasone instead of just 1mg/g betamethasone, meaning that the steroid content has actually fallen outside the registered specifications of the drug.”
Uni-Betasone 0.1% Cream is used for the treatment of inflammatory skin disorders. It can only be sold on a doctor’s prescription in a registered pharmacy and under the supervision of a pharmacist.
The spokesman reveals that thus far, DH has received no notification of related adverse event.
“On initial investigation, our inspectors note that the low solubility of betamethasone may affect the cream's homogeneity; the latter may be further exacerbated by the high alcohol content used in the formulation," the spokesman explains.
"While investigation is to continue, risk assessment indicates that the problem is likely to be quality in origin and should pose only negligible safety risk. Thus, the present recall does not involve consumers," the spokesman deliberates.
According to Universal's trade record, some 537 bottles of Uni-Betasone 0.1% Cream have been supplied to various local pharmacies as well as private doctors. Universal has set up a hotline 2963 8931 to handle related enquiries.
"Here, contravention of the Public Health and Municipal Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is a fine of $10,000 and three months' imprisonment. In any case, DH will seek Department of Justice's advice on completion of our investigation," the spokesman mentions.
“Doctors and pharmacies should stop supplying the affected product to their clients. Members of the public who have used the product should consult their healthcare providers if in doubt or feel unwell,” the spokesman urges.
