FDA issues alert on counterfeit semaglutide products in the U.S.
The U.S. Food and Drug Administration (FDA) has recently issued a crucial warning to adults with diabetes in the United States about the presence of counterfeit semaglutide in the country’s drug supply chain. This alert comes following an ongoing FDA investigation into the distribution of fake versions of the 1 mg subcutaneous semaglutide, known commercially as Ozempic and manufactured by Novo Nordisk.
The FDA’s investigation has led to the seizure of thousands of units of these counterfeit products. Key identifiers of the fake medication include lot number NAR0074 and serial number 430834149057. These specific batches have been confirmed as counterfeit and are advised not to be used.
A further cause for concern highlighted by the FDA is the discovery of counterfeit needles accompanying the medication. The sterility of these needles cannot be assured, posing a heightened risk of infection for users. Additional counterfeit components identified by the FDA include the pen label, health care professional and patient information leaflets, and the packaging box.
The FDA is urging wholesalers, retail pharmacies, healthcare providers, and patients to diligently check their semaglutide products’ lot and serial numbers. While the FDA, in partnership with Novo Nordisk, is currently conducting tests on the seized counterfeit products, there is yet no comprehensive information about the content, quality, or safety of these fakes.
To date, the FDA has received reports of five adverse events associated with the use of these counterfeit semaglutide products. These incidents align with the typical side effects of authentic semaglutide, and thankfully, none of the reported cases have been serious. The FDA encourages reporting of any adverse events through its MedWatch Safety Information and Adverse Event Reporting Program, either via online submission or fax at (1-800) FDA-0178.
The FDA advises pharmacies to source genuine semaglutide only through Novo Nordisk’s approved distributors. Patients should obtain the drug strictly with a valid prescription from state-licensed pharmacies and are advised to inspect the product thoroughly for any signs of counterfeiting before use. Any suspicions or discoveries of counterfeit products should be promptly reported to the FDA. This can be done by calling the local FDA consumer complaint coordinator or by reporting directly via the FDA’s official website.
