The Department of Health (DH) today (18 May) endorsed a licensed drug wholesaler, Johnson & Johnson (Hong Kong) Ltd. (Johnson & Johnson), to voluntarily recall 5 batches of Eprex 1000 Prefilled Syringe 1000iu/0.5ml, Eprex 4000 Prefilled Syringe 4000iu/0.4ml and Eprex 5000 Prefilled Syringe 5000iu/0.5ml (registration number: HK-39774, HK-39776 and HK-49846 respectively) from wholesalers due to potential quality issue. In other words, Johnson and Johnson is stopping the supply of the affected batches of the products. The affected batches are EBS4F00 (1000iu), EAS4300, EBS5C00 and EJS6Q00 (4000iu) and EAS4100 (5000iu).
The DH received notification from Johnson & Johnson that the impurity content of certain batches of the products was found to be elevated during stability testing by its manufacturer. Although the levels of the impurity were still within specification, Johnson & Johnson decided to recall the affected batches as a precautionary measure. According to Johnson & Johnson, only five of these affected batches were imported into Hong Kong. Since the affected batches did not fail the specifications of the products, risk posed by the issue is negligible.
So far, the DH has not received any adverse reports in connection with the products. Investigation is continuing.
Eprex 1000iu, 4000iu & 5000iu Prefilled Syringe, containing recombinant human erythropoietin epoetin alfa, is a prescription medicine used for treatment of anemia associated with chronic renal failure. According to Johnson & Johnson, 269 packs of 6 prefilled syringes of the affected batches had been supplied to private doctors, private hospitals and public hospitals.
Johnson & Johnson has set up a hotline on 2738 6144 to answer related enquiries.
Related Information:
Canada: Recall: Eprex Products Posted 2015-05-22