Recall of pharmaceutical products

15 Mar 2010

Neochem Pharmaceutical Laboratories, a licensed drug manufacturer, is recalling two products Neo-Celemine Syrup (Registration Number HK-24685) and Betamine Syrup (Registration Number HK-24681), which were found to contain lower than registered content in one of their active ingredients, betamethasone.

The batch number of both products being recalled bore the same batch number 092048.

According to the labels of Neo-Celemine Syrup and Betamine Syrup, each 5ml of the products should contain 0.25mg betamethasone. Today, testing of samples collected during the Department of Health's (DH) inspection of the manufacturer showed that the concerned products only contained 3mcg (microgram) betamethasone per 5ml.

Neo-Celemine Syrup and Betamine Syrup are used for the treatment of difficult cases of respiratory, eye, and skin allergies. They are both prescription medicines.

Deviations from the registered content of active ingredients of a pharmaceutical product would affect treatment effectiveness.

Based on information in hand, a total of 124 bottles (3.6 litres per bottle) of the affected Neo-Celemine Syrup and 150 bottles (3.6 litres per bottle) of the affected Betamine Syrup had been supplied to private doctors and some pharmacies.

The manufacturer has initiated a recall at retail level. It has also set up a hotline, 2562 6255, to answer clients' enquiries.

People who have been using Neo-Celemine Syrup or Betamine Syrup are advised to consult their doctors.

The DH will closely monitor the recall. Investigations are in progress.