No evidence of supply or harm to patients
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (18 October 2023) confirmed that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution for injection) have been identified at two UK wholesalers. All affected pens have been recalled and accounted for, and none of the pens have been supplied to UK patients.
Following investigation, the MHRA has confirmed that the products, under the brand name Ozempic, were brought in from legitimate suppliers in Austria and Germany.
The MHRA is working closely with its regulatory partners internationally to continue to maintain the security of the wider supply chain, both at home and abroad.
While the falsified pens appeared to have authentic German packaging, there are substantial differences compared with genuine pens. The German medicines agency, the Federal Institute for Drugs and Medical Devices (BfArM), have published photos of the genuine and falsified products.
There is no evidence that any of the falsified pens have been dispensed to patients from legitimate pharmacies or healthcare professionals in the UK and there are no reports of harm to patients in relation to these pens.
Dr Alison Cave, MHRA Chief Safety Officer said:
Notes to Editors