Safety Alerts and Products Recalls > Medicine recalls

Medicine recalls   Batch recall of Famotidine USP 20mg tablets   The Department of Health (DH) today (15 April) endorsed a licensed drug wholesaler, Eugenpharm International Ltd ("Eugenpharm"), to recall two batches (batch numbers: TE-4846 and TE-4847) of Famotidine USP 20mg tablets (HK-54490) from the market because the outer boxes of these products do not match with the registered particulars. Acting on a complaint, investigation carried out at Eugenpharm found that outer boxes of a new design were used in the secondary packaging of these two batches of products. However, such change in the outer box has not been approved by the Pharmacy and Poisons Board and renders the product unregistered. Since the supply of unregistered pharmaceutical products contravenes the Pharmacy and Poisons Regulations (Cap. 138A), Eugenpharm voluntary recalls the products from the market. DH's investigation is continuing. According to the Pharmacy and Poisons Regulations, illegal sale of unregistered pharmaceutical products is an offence and the maximum penalty upon conviction is a fine of $100,000 and 2 years' imprisonment. The above product contains famotidine is an over-the-counter medicine used for the treatment of gastric ulcer and duodenal ulcer. According to Eugenpharm, about 10,000 boxes (each box contains 100 tablets) from the two affected batches have been supplied to private doctors and local pharmacies. So far, the DH has not received any adverse reports in connection with the products concerned. Eugenpharm has set up a hotline (3647 3781) to answer related enquiries. The DH will closely monitor the recall.