Skip to content

Press Release

DH instructs batch recall of Betasalic Ointment

16 March 2015

The Department of Health (DH) today (March 16) instructed a licensed pharmaceutical manufacturer, Europharm Laboratoires Co Ltd (Europharm), to recall one batch (batch number: 408179) of Betasalic Ointment (registration number: HK-49244) from the market due to a quality issue.

Under the DH's market surveillance, samples of Betasalic Ointment were taken for analysis. Upon the Government Laboratory's testing, the content of one of the active ingredients, betamethasone, was found to be lower than the labelled claim in samples of the above batch. The root causes of the issue are still under investigation. Since the quality defect may affect the efficacy of the pharmaceutical product, Europharm was ordered to recall the affected batch from the market.

According to Europharm, the affected batch was manufactured in August 2014 and 6 379 tubes have been supplied to public hospitals under the Hospital Authority, pharmacies and private doctors in Hong Kong. Investigations are ongoing and the DH will closely monitor the recall.

Betasalic Ointment, containing betamethasone and salicylic acid, is a prescription medicine indicated for the relief of inflammation of the skin. Side-effects include ulceration of the skin, moon face, high blood pressure, high blood sugar, muscle atrophy, adrenal insufficiency or even osteoporosis.

So far, the DH has not received any adverse reports in connection with the above pharmaceutical product. Europharm has set up a hotline (2666 3392) to answer public enquiries.

"Using ointment with content lower than its labelled claim may lead to delayed treatment due to insufficient efficacy. Members of the public using the above pharmaceutical product should consult their healthcare providers if in doubt or when symptoms persist," a spokesman for the DH said.

Photo shows Betasalic Ointment under batch recall.

16 March 2015