The Department of Health (DH) today (July 23) endorsed a registration certificate holder, Bayer Healthcare Ltd. (Bayer), to recall all batches of Nexavar Tablet 200mg (Hong Kong Registration Number: HK-55409) from the market because the package insert of the product does not match with the registered one. The product is distributed in Hong Kong by Zuellig Pharma Ltd.
The DH received notification from Bayer today that the package insert of the product was different from that of the registered one. Although the differences were mainly textual in nature and did not involve indication or dosage, bearing with the unapproved package insert render the product unregistered. In this connection, Bayer voluntary 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 sorafenib, is a prescription medicine used for the treatment of various cancers. According to Bayer, the product has been supplied to the Hospital Authority, private hospitals, private doctors and local pharmacies.
Bayer has set up a hotline (2814 4808) to answer related enquiries. The DH will closely monitor the recall.
Patients who have used the above product should seek advice from their healthcare professionals if in doubt.
Reposted from HKSAR Government webpage:
https://www.drugoffice.gov.hk/eps/news/showNews/Recall+of+Nexavar+Tablet+200mg/pharmaceutical_trade/2020-07-23/en/40892.html