The Pharmacy and Poisons Board (PPB) has issued an alert over fake radiographic contrast agent in the market.
The board confirmed that substandard and falsified (SF) batches of Visipaque (Iodixanol) 320 mg/mL vials had infiltrated the market illegally by importation and distribution through unauthorised and illegal supply chains.
The contrast agent is commonly used by radiographers during certain medical procedures, such as CT scans and angiography.
The Board (PPB) confirmed that it has received several complaints regarding quality defects and suspected adverse events.
The affected products are Visipaque (Iodixanol) 320 mg/mL manufactured by GE Healthcare Ireland, Cork Ireland: Batch Number 15950809, 15944839, 15950792 and 15906117.
The other is manufactured by GE Healthcare (Shanghai) Co., Ltd, China: Batch Number 5389618, 15429745, 15444386, 15661498, 15904073, 15751274, 16017833, 16044911, 16085815, 16100415, 16107210 and 16177061
In an effort to safeguard public health and safety, healthcare facilities in possession of these affected product batches are urged to immediately quarantine the products and report to the Pharmacy and Poisons Board offices for further guidance and necessary action.
The board warned that it will take legal action against unscrupulous people who are engaging in illegal trading in pharmaceuticals have been warned.
“Further, the PPB strongly cautions the public against engaging in any form of trade, distribution, wholesale, retail, issuance, dispensing or use of this product due to the serious safety and health risks it poses. Any person found handling or distributing these products will be subject to legal action”.