FDA warns adults with diabetes about counterfeit semaglutide products
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The FDA is warning adults with diabetes to avoid using counterfeit semaglutide that may be circulating in the U.S. drug supply chain, according to a press release.
The FDA said it is investigating the distribution of counterfeit 1 mg subcutaneous semaglutide (Ozempic, Novo Nordisk) and has seized thousands of units of the fake product. Products with the lot number NAR0074 and serial number 430834149057 are counterfeit and should not be used.
The FDA has also found that needles included with the product are counterfeit. The sterility of the needles cannot be confirmed, and consumers have an increased risk for infection if they use them. Other confirmed counterfeit components included the pen label, health care professional and patient information, and carton.
Wholesalers, retail pharmacies, providers and patients are asked to check the lot number and serial number of their products. The FDA and Novo Nordisk are testing the seized products. No information is available about the identity, quality or safety of the counterfeit products.
Five adverse events have been reported to the FDA from counterfeit semaglutide products. All of the adverse events are consistent with common adverse reactions to authentic semaglutide, and none are serious. Adverse events can be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by submit a report online at www.accessdata.fda.gov/scripts/medwatch or by downloading and completing a form and then submitting it by fax to (1-800) FDA-0178.
Pharmacies should purchase authentic semaglutide only through distributors of Novo Nordisk. Patients should obtain the drug only with a valid prescription through state-licensed pharmacies and check the product before use for signs of counterfeiting. Suspected counterfeit products can be reported to the FDA by calling a local FDA consumer complaint coordinator or by reporting it directly at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm.