Safety Alerts and Products Recalls > Medicine recalls

Medicine recalls   Recall of three batches of Gaster Capsules 20mg (Each box contains 28 capsules)   The Department of Health (DH) today (January 17) endorsed a licenced pharmaceutical secondary packaging manufacturer, Sources (U.S.A.) Medicines Ltd (Sources), to recall three batches (Batch number: A0501, A0504 and A0603) of Gaster Capsules 20mg (Each box contained 28 capsules) (Hong Kong Registration Number: HK-52562) from the market because the outer box of the product does not match with the registered one. During the DH routine inspection, it was found that the outer box of the above product was not labeled with “Drug under Supervised Sales” in accordance with the legal requirement and thus different from the registered label. This renders the product unregistered. Since the supply of unregistered pharmaceutical product contravenes the Pharmacy and Poisons Regulations (Cap. 138A), Sources voluntarily recalls the product from the market. DH's investigation is continuing. According to the Pharmacy and Poisons Regulations, sale of unregistered pharmaceutical product is an offence and the maximum penalty upon conviction is a fine of $100,000 and 2 years’ imprisonment. The above product, containing Part 1 poison omeprazole, is used for treatment of gastric ulcer and gastro-oesophageal reflux syndrome. According to Sources, the product has been supplied to local pharmacies. So far, the DH has not received any adverse reaction report in connection with the affected product. Source has set up a hotline (2412 1248) to answer related enquiries. The DH will closely monitor the recall.