PPB warns against fake radiocontrast agent Visipaque
By Francis Muli, September 20, 2023The Pharmacy and Poisons Board (PPB) has warned the public against the use of suspected substandard and falsified radiocontrast agent Visipaque (Iodixanol) 320mg/mL vials.
In a statement, PPB said that the product had infiltrated the market illegally, having been imported and distributed through unauthorized and illegal supply chains.
“The Pharmacy and Poisons Board (PPB) has received several complaints regarding quality defects and suspected adverse events associated with suspected substandard and falsified (SF) batches of Visipaque (Iodixanol) 320 mg/mL vial. In light of these concerns, the PPB initiated preliminary investigations, which revealed that the affected product batches had infiltrated the market illegally, having been imported and distributed through unauthorized and illegal supply chains,” PPB stated.
The affected product batches include Visipaque (Iodixanol) 320 mg/mL manufactured by GE Healthcare Ireland, Cork Ireland, batch numbers 15950809, 15944839, 15950792 and 15906117 and Visipaque (Iodixanol) 320 mg/mL manufactured by GE Healthcare (Shanghai) Co., Ltd, China, batch numbers 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,” PPB added.
“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.”
PPB has urged members of the public and healthcare providers to promptly report any suspected substandard and falsified medical products.
Temadol recalled
PPB has also recalled Tamedol Oral Solution (Paracetamol Oral Solution, 120mg/5ml, 60 mls) by Biopharma Ltd, Kenya, over quality concerns.
“In response to these concerns, the PPB upon investigations, indeed confirmed that the product failed to meet the prescribed market authorization requirements and has initiated mandatory recall of the product by the manufacturer in line with Section 3A(i) of the Pharmacy and Poisons Act (Cap. 244).”
PPB has urged pharmaceutical outlets, healthcare facilities, healthcare professionals and members of the public to stop all further distribution, sale, issuing or use of Tamedol oral solution.