Substandard semaglutide vials

The Therapeutic Goods Administration (TGA) has tested a product, labelled ‘Semaglutide 2.64mg/mL, L-carnitine 100mg/mL B12 .05mg/mL solution for SC injection 3’, and found that: 

• the vials contain ten times the amount of vitamin B12 (cyanocablamin) labelled
• the content of L-carnitine, was estimated at 0.5-0.7mg/mL, well below the labelled 100mg/mL

Consumers are advised that semaglutide is a prescription-only medicine in Australia. 

The medicine consisted of a distinctive red coloured liquid, which is not the expected appearance, in blue capped vials. Although it was purported to be compounded, the medicine was supplied to patients via regular mail, not purchased and dispensed from an Australian pharmacy.

Subcutaneous injection of this compounded semaglutide-like product is alleged to have resulted in the hospitalisation of a patient for peripheral neuropathy.

The product tested is not included in the Australian Register of Therapeutic Goods (ARTG), and has not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation. The place of manufacture has not been determined.

The compounding of semaglutide-like products by individuals who hold no formal qualifications and in unsterile environments poses a serious risk to human health. 

The TGA has published specific compounding safety information for semaglutide-like products. Consumers should be aware that medicines manufactured by compounding pharmacists are not assessed by the TGA for safety, quality, or efficacy.

Information for consumers

• If you have any concerns arising from your use of this or a similar medicine, 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, retain the sample and report it to the TGA. 
• Do not use compounded semaglutide offered or issued without a prescription, or where the origins of its manufacture cannot be determined. 
• If you have compounded semaglutide of unknown origin, or purchased a similar product without a prescription, you should take any remaining vials to your local pharmacy for safe disposal.
• If you suspect you have had a side effect (also known as an adverse event) to this product, please retain the sample and report it to us. In addition, if you have concerns about this or other products, you can make a report to the TGA on 1800 020 653 or through our website.

Action the TGA is taking

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. 

Products purchased over the Internet:

• may contain 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.

Report counterfeit medicines and medical devices

If you are worried about Counterfeit (fake) medicines and medical devices, and want to report an issue, you can report the matter to us: