FDA warns over counterfeit Ozempic

The US FDA has issued another warning about counterfeit versions of Novo Nordisk’s diabetes therapy Ozempic, saying it has seized “thousands of units” of the product.

The Ozempic (semaglutide 1mg) injections have been found in the legitimate US drug supply chain, said the regulator in an alert. It is advising wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labelled with lot number NAR0074 and serial number 430834149057 as pictured below:

The FDA and the manufacturer are testing the seized products but do not yet have information about the drugs’ identity, quality, or safety.

Additionally, analysis found the needles from the samples are counterfeit, according to the regulator. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products.

Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.

“FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply,” said the agency in its alert.

“FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the US.”

This is the latest in a string of reports of counterfeit Ozempic around the globe, driven by shortages of the medicine which is in high demand for its weight-loss properties.  

As a result, Novo Nordisk has implemented national and international sales restrictions and limited new starts on therapy. In some cases, exposure to the counterfeits has been shown to have caused harm to patients.