Company statement

Novo Nordisk warns of counterfeit Ozempic® (semaglutide injection) pen found in US

• Company is committed to patient safety and helping the public identify any potential counterfeit semaglutide injectable products that enter the US market
• Patients prescribed semaglutide injectable products are urged to be vigilant in checking their medicine to confirm it is authentic before administration

PLAINSBORO, N.J., June 16, 2023 – Novo Nordisk is working with the US Food and Drug Administration (FDA) and is alerting the public that a counterfeit Ozempic^® (semaglutide injection) pen was found in the US. The product was reportedly purchased at a retail pharmacy and the company is actively investigating the report and collaborating with the FDA to identify the origin and distribution of the counterfeit pen. The counterfeit product appears to have contained another type of diabetes medication, insulin glargine injection, that works differently than Ozempic^®, which reportedly led to an adverse reaction.

Patients prescribed semaglutide injectable products, FDA-approved and marketed under the brand names Ozempic^® and Wegovy^®, should be vigilant in checking their medicine to ensure they are taking an authentic, Novo Nordisk produced version of the authorized drug and injection device. The safety or efficacy of counterfeit products cannot be assured and they should not be used. Potential risks of taking a counterfeit medicine include serious adverse events.

Medications purchased online or in-person from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Purchasing and administering counterfeit, illegal and unapproved medications from online or in-person unlicensed or foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment.

Please see the pictures and details below to identify differences between an authentic FDA-approved Ozempic^® pen in the US and counterfeit product:

 

Authentic Ozempic® Pens	Counterfeit Product
With Cap Without Cap	With Cap       Without Cap
Authentic Ozempic® Carton	Counterfeit Carton
WHAT TO LOOK FOR: OZEMPIC® PEN AND CARTON Genuine: Genuine Novo Nordisk Ozempic® pens do not extend or increase in length when setting the dose. The dose dial window only shows intended doses: On the pen intended to deliver 0.25/0.5 mg doses, it only shows -0-, 0.25 and 0.5 once dialed up to the intended doses On the pen intended to deliver 1 mg dose, it only shows -0- and 1 mg once dialed up to the intended dose On the pen intended to deliver 2 mg dose, it only shows -0- and 2 mg once dialed up to the intended dose Authentic Ozempic® pens are currently available in the following configurations: 0.25/0.5 mg pen 1 mg pen 2 mg pen The box containing authentic Ozempic® will include 4 needles which attach directly onto the pen, except the Ozempic® 0.25/0.5 mg dose carton which has 6 needles. Counterfeit: A counterfeit pen may be identified based on scale extending out from the pen when setting the dose. The label on a counterfeit pen could be of poor quality and may not adhere well to the pen. A counterfeit carton may have spelling mistakes on the front of the box (i.e., 1pen and 4 doses without space between ‘1’ and ‘pen’) as seen in photo above. A counterfeit carton may not include the tamper resistant/perforation. The batch number printed on a counterfeit box may not correspond to the product strength stated on the same box and pen.

Although no counterfeit Wegovy^® pens have been reported to date in the US, information on authentic Wegovy^® pens is presented below:

Authentic Wegovy® (semaglutide injection)

WHAT TO LOOK FOR: WEGOVY® Genuine: Genuine Novo Nordisk Wegovy® pens are fixed-dose auto-injectors and do not have a push button to administer the medicine.  Genuine Novo Nordisk Wegovy® pens do not have an option to set a dose and do not extend or increase in length. Wegovy® is currently available in the following configurations: 0.25 mg pen 0.5 mg pen 1 mg pen 1.7 mg pen 2.4 mg pen

Patient safety is a top priority for Novo Nordisk and the company is committed to working with the FDA to identify and investigate any potential counterfeit semaglutide injectable products found in the US. Semaglutide.com is available as a resource hub for US consumers, healthcare providers and retailers to provide information about responsible use of semaglutide, including how to spot a counterfeit product.

WHAT TO DO: GUIDANCE FOR RETAILERS AND CONSUMERS

Retail pharmacies and consumers are advised to purchase authentic semaglutide medicines through authorized distributors of Novo Nordisk and reliable sources. Pharmacies are encouraged to review the photographs and information provided above and confirm that they are dispensing authentic semaglutide products to patients. Patients are also encouraged to check the product before using it to ensure its authenticity.

To report counterfeit semaglutide products or any suspected Novo Nordisk counterfeit products, please call Novo Nordisk customer care at 1-800-727-6500 Monday through Friday from 8:30 AM to 6:00 PM EST.

If an individual is experiencing any side effects that may be related to the use of a counterfeit product, that person should immediately discontinue use and contact their health care provider, and is additionally encouraged to report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch) as well as to Novo Nordisk, using the same customer care number (1-800-727-6500).

Websites selling counterfeit and/or tampered medicines should be reported to the FDA. Suspected counterfeit products may be reported to FDA by calling the FDA’s Office of Criminal Investigations (OCI) at 1-800-551-3989 or a local OCI field office.

About Ozempic^®
Ozempic^® (semaglutide) injection 0.5 mg, 1 mg or 2 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes with known heart disease.

About Wegovy^®
WEGOVY ^® (semaglutide) injection 2.4 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated for chronic weight management in adults and adolescents aged ≥12 years with obesity (BMI ≥30 for adults, BMI ≥ 95th percentile for age and sex for adolescents), or some adults with excess weight (BMI ≥27) (overweight) who also have weight-related medical problems. Wegovy ^® should be used with a reduced calorie meal plan and increased physical activity.