Federal officials are urging pharmacies, patients and health care professionals to inspect their Ozempic carefully after hundreds of counterfeit units were discovered in the U.S. drug supply chain.
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Federal officials are urging pharmacies, patients and health care professionals to inspect their Ozempic carefully after hundreds of counterfeit units were discovered in the U.S. drug supply chain.
The Food and Drug Administration confirmed it seized counterfeit Ozempic (semaglutide) injection 1 mg on April 9, following an alert from manufacturer Novo Nordisk just days earlier. The company notified the FDA on April 3 that the counterfeit products were circulating outside its authorized distribution network.
Although six adverse events have been reported in connection with the affected lot, all reports came from Novo Nordisk and do not appear related to the fake product. The FDA and Novo Nordisk are testing the seized items, but no information is yet available about the identity, quality or safety of the counterfeit drugs. The investigation remains ongoing.
Ozempic is a prescription medication used alongside diet and exercise to help adults with type 2 diabetes improve blood sugar levels and reduce the risk of major cardiovascular events. It belongs to a class of drugs known as GLP-1 receptor agonists.
The counterfeit products are labeled with lot number PAR0362 and serial numbers beginning with 51746517. The FDA advises all wholesalers, retail pharmacies and health care professionals to immediately check their inventory and stop using, distributing or selling any products matching that description.
Patients should only obtain Ozempic through state-licensed pharmacies and confirm the drug's legitimacy before use. Retail pharmacies are urged to purchase the medication only from Novo Nordisk's authorized distributors and to review packaging closely to avoid counterfeit shipments.
Anyone who suspects they have received a counterfeit product, or who wants to report suspicious activity, should contact the FDA. Online sellers and other entities distributing counterfeit or tampered drugs should also be reported.
To report side effects or adverse events, contact the FDA's MedWatch Safety Information and Adverse Event Reporting Program by visiting www.fda.gov/medwatch. Consumers may also call (800) 332-1088 to request a form or fax it to (800) FDA-0178.
Novo Nordisk's customer care line is available at (800) 727-6500 for patients or retailers with questions or concerns. More information, including images of the counterfeit packaging, is available at www.novonordisk-us.com.