EMA Warns About Falsified Ozempic Pens

On Oct. 18, 2023, the European Medicines Agency (EMA) announced that national competent authorities have notified the agency that pre-filled pens falsely labeled as Ozempic (semaglutide, 1 mg, solution for injection) have been found at wholesalers in the European Union (EU) and the United Kingdom. EMA stated in a press release that these reports of fake Ozempic follow an increase in demand for the diabetes medication, which has also created a shortage of the drug.

The pens’ labels are in German and originated in Austria and Germany. The falsified pens include genuine information from Ozempic packs including batch numbers, 2D barcodes, and unique serial numbers. According to EMA, the serial numbers came up as inactive when they were scanned. The falsified pens also differ in appearance from the genuine pens. A photo of the falsified pen can be found on the German medicines agency’s website.

Regulators in the EU and police are investigating the falsified pens, and wholesalers and pharmacies have been warned of “suspicious offers of Ozempic.” German and Austrian regulators have issued statements of non-compliance with good distribution practices to wholesalers. It is recommended that wholesalers and pharmacies use caution with purchasing Ozempic from supplier and that packages be checked in the verification system.

EMA is advising patients to check the patient information leaflet that comes with the medication to be sure the pen looks correct. If they suspect the pen is fake, they should not use the medication and return the product to the pharmacy. However, the agency reports that there is no evidence that the falsified products have been given to patients from legal pharmacies.

The agency is monitoring the situation and will provide updates as they are available.

Source: EMA