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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Slim Fit capsules

Slim Fit capsules pose a serious risk to your health and should not be taken.

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

the capsules contain the undeclared substance sibutramine

  • consumers are advised that sibutramine is a prescription-only substance
  • Sibutramine was withdrawn from world markets in 2010 due to increased risk of cardiac events and stroke.

The supply of Slim Fit capsules is illegal.

Slim Fit capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

TGA investigations have shown that a number of people in Australia may have bought the product online.

Information for consumers

Slim fit capsules pill bottle front view

  • Stop taking Slim Fit capsules and take any remaining capsules to your local pharmacy for safe disposal(link is external).
  • If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with Australian Customs and Border Protection Service (ACBPS) to help stop future shipments of Slim Fit capsules from entering Australia.

If these capsules are found at the border by ACBPS they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites. 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.