So Hard for Men tablets

Safety advisory

26 May 2014

So Hard for Men tablets pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) in October 2010 advised that this product was found to contain the undeclared prescription substance tadalafil. The TGA has tested a further product labelled So Hard for Men tablets and found that:

  • it contains the undeclared substances Yohimbine and hydroxyhomothiosildenafil an analogue of sildenafil.
  • image of the So Hard for Men packagingconsumers are advised that both Yohimbine and hydroxyhomothiosildenafil are prescription-only medicines.

The supply of So Hard for Men tablets is illegal. The substance Yohimbine is a prohibited import into Australia under the Customs (Prohibited Imports) Regulations 1956 (Cth).

So Hard for Men tablets 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 have bought the product online.

Information for consumers

  • Stop taking So Hard for Men tablets and take any remaining tablets to your local pharmacy for safe disposal.
  • 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 Services (ACBPS) to help stop future shipments of So Hard for Men tablets from entering Australia.

If these tablets 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.

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 of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email: info@tga.gov.au