Counterfeit Ozempic pens detected and adverse event reported

Consumers and health professionals should be aware that counterfeit Ozempic-labelled pens have been imported into Australia. These pens may pose a serious health risk and should not be used. There are clear inconsistencies from the original product to look out for.

We have received one report of a life-threatening adverse event in Australia after a person used counterfeit pen labelled as Ozempic that contained insulin. This pen was bought overseas. Insulin is a different type of medicine that should only be used when directed and prescribed by a health professional. Unintended use of insulin can cause dangerously low life-threatening blood sugar levels.

About the counterfeit Ozempic pens

The Therapeutic Goods Administration (TGA), in collaboration with the Australian Border Force (ABF), has detected counterfeit Ozempic-labelled pens being imported into Australia.

Laboratory testing has confirmed that both pre-filled pens contain the undeclared substance Insulin Glulisine.

Both the product detected by ABF and the one associated with the adverse event exhibit several inconsistencies compared to legitimate Ozempic pens. 

Counterfeit products may have spelling errors, instruction leaflets not in English, unsealed packaging, changes in medicine size, shape, or appearance. These are indicators that the medicine has not been produced by the original manufacturer or is being illegally sold in the wrong market.

The two products subject to this alert both appear to be relabelled insulin pens. The end cap is blue (not grey), the dosage barrel is in a different place, the sticker is not adhering properly to the pen and the rendering of the packaging is poor quality. 

The batch numbers labelled on the pens - NPSG234 detected by ABF and JS7A925 from the adverse event – have been confirmed as not genuine batch numbers by Novo Nordisk, the manufacturer of Ozempic. 

Consumers should be warned that manufacturers of counterfeit goods are producing products that, to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources.

Similar counterfeit products identified overseas have been associated with life-threating adverse events, including hospitalisation, due to insulin being unknowingly injected instead of the expected semaglutide.

The products detected by ABF were purchased online from an overseas website and imported under the personal importation scheme; they were not bought from an Australian pharmacy.

Although consumers who hold a valid prescription can lawfully import prescription-only medicines such as Ozempic (semaglutide) under the personal importation scheme, counterfeit products − whether bought knowingly or unknowingly − cannot be imported under any circumstances, even if a prescription is provided. 

We remind consumers that products purchased over the internet:

• may be fake
• may contain the wrong or undisclosed and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

For your safety, always buy medicines from reputable sources and consult your healthcare provider or local registered pharmacy if you have any concerns. We strongly advise extreme caution when buying medicines from unknown overseas websites and recommend obtaining them from an Australian pharmacy.

From 1 October 2024, Australian pharmacies will not be allowed to compound glucagon-like peptide-1 receptor agonists (GLP-1 RAs) like Ozempic (semaglutide). Visit our news alert for more information. 

Action the TGA is taking

The TGA continues to check batch numbers of any products that may be subject to counterfeiting.

We are working with the ABF to help stop future shipments of counterfeit and substandard Ozempic from entering Australia. 

We will notify ABF to seize and destroy any of these products intercepted at the border. 

We are also working to provide consumers with safe alternatives, such as approving the importation of legitimate overseas-registered semaglutide products for temporary supply. Details about these overseas-registered products are available on the section 19A approvals database on the TGA website. 

Information for consumers

• Call 000 or get other emergency medical assistance if you or someone else has symptoms of severe low blood sugar levels (hypoglycaemia) after using a product labelled as Ozempic. This might include weakness, trembling, shaking, confusion and unconsciousness. Go to the Health Direct website for more information. 
• If you have any other concerns about using a product labelled as Ozempic, consult your health care practitioner. 
• If you suspect you have had a side effect (also known as an adverse event) to this or a similar medicine, report it to the TGA. 
  • If possible, keep the medicine, as the TGA may request it for testing
• If you are considering buying medicines or medical devices online from overseas, watch this short video on the risks associated with doing this.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA. If you have a medicine you suspect may be counterfeit, please do not dispose of it as the TGA may request it for testing.

Photos:

1. Example of a falsified Ozempic® pen (top) compared to a genuine Novo Nordisk Ozempic® pen (bottom).

ABF detected import photos

Adverse Event product photos