Fitaro semaglutide pre-filled syringe (various dosage strengths)

Consumers and health professionals should be aware that examples of substandard Fitaro semaglutide pre-filled syringes have been stopped at the Australian border. These products may pose a risk to your health and should not be used.

We have conducted testing on several Fitaro-branded pre-filled syringes labelled as containing semaglutide.  Laboratory analysis found the following dosage strengths contain less than the stated amount of the active pharmaceutical ingredient, semaglutide:

• 0.25mg
• 0.5mg
• 1mg
• 1.7mg
• 2.4mg

As there is a misleading representation, we will treat them as counterfeit. Fitaro-branded pre-filled syringes have not been assessed by us for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is also not approved by us.

We advise consumers to exercise extreme caution when buying medicines and medical devices online. 

Products purchased over the internet:

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

For your safety, always buy medicines and medical devices from reputable sources and consult your healthcare provider or local registered pharmacy if you have any concerns.

Counterfeit products cannot be imported under the Personal Importation Scheme. Knowingly importing, supplying and/or giving away counterfeit therapeutic goods is illegal and poses a significant public health and safety risk.

Information for consumers

• Stop using substandard Fitaro-branded prefilled syringes and take any remaining product to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, 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 we may request it for testing.
• If you are considering purchasing medicines from overseas watch this short video on the risks associated with buying medicines and medical devices online.

Action we are taking

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

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: