FDA, Novo Nordisk Warn of Counterfeit Semaglutide Injection Pens

The FDA and Novo Nordisk have reported that a counterfeit semaglutide injection (Ozempic) pen was found in the United States. According to a company press release, the medication was reportedly purchased at a retail pharmacy, appearing to have contained another type of diabetes medication called insulin glargine injection, which works differently than semaglutide and lead to an adverse event (AE).

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Novo Nordisk has been working with the FDA to investigate the origin and distribution of the counterfeit pen. The company has issued a statement that individuals who have obtained semaglutide injectable products that are FDA-approved under the brand names Ozempic and Wegovy (Novo Nordisk) should make sure they are taking an authentic product of the authorized drug and injection device. The statement said that the safety and efficacy of the counterfeit products cannot be assured and should not be used as serious AEs can occur.

Additionally, the statement said that medications purchased online or in-person from foreign or unlicensed sources could have a variety of issues, including products that are misbranded, adulterated, counterfeit, contaminated, improperly stored or transported, ineffective, and/or unsafe. The company added that using these medications could be putting the patient and their health at risk.

Genuine vs Counterfeit Ozempic - Novo Nordisk

To determine whether a Novo Nordisk Ozempic pen is genuine, look for:

• A pen that does not extend or increase in length when setting the dose.
• A dial window that shows intended doses only.
  • On a pen for 0.25/0.5 mg doses, -0-, 0.25 and 0.5 dosages should eb the only doses shown when dialed to the intended dose.
  • For the 1 mg dose, only the -0- and 1 mg dosage should be shown when dialed to the intended dose.
  • For the 2 mg dose, only the -0- and 2 mg dosage should be shown when dialed to the intended dose.
• Authentic pens are only available in the 0.25/0.5 mg, 1 mg, and 2 mg pens.
• The box containing authentic Ozempic should include 4 needles when attached directly to the pen, except for the 0.25/0.5 mg dose, which has 6.

Counterfeit pens can be identified:

• When the scale extends out from the pen when setting the dosage.
• When the label on the pen could be of poor quality and may not adhere well to the pen.
• When the carton has spelling mistakes on the front of the box.
• When the carton does not include the tamper resistant/perforation.
• When the batch number printed on the box may not correspond to the product strength on the same box and pen.

Although there have been no counterfeit Wegovy pens reported to date in the United States, Novo Nordisk cautions consumers and pharmacies about the possibility of counterfeit Wegovy.

Genuine Wegovy - Novo Nordisk

Genuine Wegovy pens have fixed-dose auto-injectors and do not have a push to administer button. Additionally, they do not have an option to set a dose or extend/increase in length.

Wegovy is currently available in 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg pens.

The company suggests that retail pharmacies and consumers should purchase medication through authorized distributors and reliable sources. Pharmacists should review the photographs and information detailing counterfeit medication to confirm the dispensing medication is authentic. Patients should also check the product before use, according to the statement.

The company said that any patients experiencing AEs related to the use of counterfeit products should discontinue the medication immediately and contact their physician.

To report AEs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, call 1-800-FDA-1088 or visit www.fda.gov/medwatch.

To report counterfeit semaglutide products or suspected Novo Nordisk products, Novo Nordisk urges individuals to call their customer care line at 1-800-727-6500 Monday through Friday from 8:30 am to 6 pm EST.

Additionally, all websites that are selling counterfeit and/or tampered medications should be reported to the FDA’s Office of Criminal Investigation at 800-551-3989 or at a local Office of Criminal Investigation field office.

Reference

Novo Nordisk warns of counterfeit Ozempic (semaglutide injection) pen found in US. News release. Novo Nordisk. June 16, 2023. Accessed June 20, 2023. https://www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=166119