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777K products

Safety advisory

3 November 2021

777K products pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled 777K capsules and found that:

  • The undeclared substance sildenafil is contained in the capsules.
  • Sildenafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates.
  • Consumers are advised that sildenafil is a Schedule 4 (prescription only medicine) that is included in the current Poisons Standard.

In Australia, advertising and supply of 777K capsules is illegal, as the product has not been entered in the Australian Register of Therapeutic Goods (ARTG). The TGA has not assessed the product and the manufacturer has not been approved.

Under the Therapeutic Goods Act 1989, prescription only medicines pose a higher level of risk and are entered into the ARTG after evaluation for quality, safety and efficacy.

Information for consumers

  • Stop using 777K capsules and take any remaining products to your local pharmacy for safe disposal.
  • If you have used any of these products and have concerns, consult your health care practitioner.
  • online report to the TGA or telephone 1800 020 653.
  • If you have concerns about any product (therapeutic goods) you can also make a report to the TGA.

Sildenafil is used to treat erectile dysfunction (ED) which is a relatively common condition that can affect men of all ages. The TGA strongly advises consumers to consult with a doctor to determine the cause of their ED and to identify safe and appropriate treatment options.

Products sold online that are not entered in the ARTG, and often do not request a doctor’s prescription, may be counterfeit, contain undeclared ingredients and could cause unexpected or severe adverse reactions. A lack of manufacturing and testing standards can also result in contaminated products.

TGA action

The TGA is working with the Australian Border Force (ABF) to stop future shipments of 777K capsules entering Australia. The ABF will seize and destroy the product as it is intercepted at the Australian 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:

Phone: 1800 020 653

Online: Report a perceived breach or questionable practices