Recall of Uni-Betasone 0.1% Cream
Hong Kong (HKSAR) - The Department of Health (DH) today (February 7) instructed a licensed drug manufacturer, Universal Pharmaceutical Laboratories Limited (Universal), to recall from shelves all batches of Uni-Betasone 0.1% Cream (registration number: HK-58723) because of a suspected quality defect.
A DH spokesman said, "During the DH's routine inspection of Universal, a sample of the above product was drawn for end product analysis. Subsequently, the Government Laboratory found it to contain 1.2mg/g betamethasone instead of just 1mg/g betamethasone, meaning that the steroid content had 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 revealed that thus far the DH has received no notification of related adverse events.
"On initial investigation, our inspectors noted 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 said.
"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."
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 at 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, the DH will seek the Department of Justice's advice on completion of our investigation," the spokesman said.
"Doctors and pharmacies should stop supplying the affected product to their clients. Members of the public who have used the product should consult their health-care providers if in doubt or feeling unwell," the spokesman urged.
Source: HKSAR Government
Published on: 2012-02-07
Limited copyright is granted for you to use and/or republish any story on this site for
any legitimate media purpose as long as you reference 7thSpace and any source mentioned in the story above. Please
make sure to read our disclaimer prior to contacting 7thSpace Interactive. To contact our editors, visit our online helpdesk. If you wish submit your own press release, click here.
Social Bookmarking
RETWEET This! | Digg this! | Post to del.icio.us | Post to Furl | Add to Netscape | Add to Yahoo! | Rojo
|
|
