Regulatory agencies have confirmed that falsified Ozempic 1mg solution for injection pens have been identified at wholesaling sites in the UK and Europe. The pens were labelled as Ozempic and purchased from two wholesalers in Austria and Germany who held a WDA.
Ozempic is currently approved to treat type 2 diabetes however demand for the product has significantly increased recently due to off label use for weight loss although the drug has not been approved by the regulatory authorities for this indication.
The falsified products were identified whilst scanning the packs as part of FMD checks. The serial numbers appeared inactive on the FMD system which prompted further investigation which later confirmed the products were falsified.
The two wholesalers involved have been issued with GDP non-compliance notices thereby prohibiting wholesale operations at both sites pending investigation.
It doesn’t appear that any falsified product has been sold to patients through the approved channels therefore limiting patient risk on this occasion however this reiterates the importance of adequate FMD checks and purchasing from approved qualified suppliers.
WDA holders throughout the EU and UK should remain alert and ensure adequate controls are in place to prevent the introduction of falsified medicines into the supply chain.
If you would like to discuss how Acorn Regulatory can support your FMD/WDA requirements, please get in touch at enquiries@acornregulatory.com.
