Falsified Medicines: MHRA publishes Class 4 FMD Medicines Information

Recommendation
Thursday, 2 October 2025 9 .30 - 16.45 h
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via WDA(H) 50340 HMS Wholesale Limited. This license has since then been terminated.
In a Falsified Medicines Directive (FMD) Alert published 19 March 2020, the MHRA says that "the products do appear to be genuine with legitimate batch numbers. These products are thought to have been stolen from the legitimate supply chain in early 2019 and reintroduced into the supply chain between May and August 2019. This means that the correct transport and storage conditions cannot be guaranteed and while unlikely, could impact their effectiveness."
Only the batch numbers mentioned in appendix 1 of the PDF are within the scope of this alert. You can download the document here.
Related GMP News
16.09.2025BioPhorum Survey on -40 °C Drug Substance Storage Practices
16.09.2025GDP Non-Compliance Report: No Responsible Pharmacist
16.09.2025Results of the GDP Survey: Detailed Report Available for Download
12.08.2025GDP Implementation Survey: Brief Summary
12.08.2025Storing Medicinal Products Outdoors? Not a good Idea!