Lilly Icos Cialis 20mg tablets (Lot numbers 05668 and AD47385 - counterfeit)

Safety advisory

1 February 2015

Lilly Icos Cialis 20mg tablets (Lot numbers 05668 and AD47385) are counterfeit and pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Lilly Icos Cialis 20mg tablets (Lot numbers 05668 and AD47385) and found that:

  • Image of the counterfeit Lilly Icos Cialis 20mg tablets box packagingthe outer carton of these tablets contain Lot number AD47385 with expiry date 04 2017 while the foil blister trays inside contain Lot number 05668 and expiry date 09 2018
  • the TGA has confirmed these are counterfeit Lot numbers
  • the tablets do not contain the stated label ingredient tadalafil
  • the tablets contain the undeclared substance sildenafil
  • consumers are advised that sildenafil is a prescription-only substance.

The supply of counterfeit Lilly Icos Cialis 20mg tablets (Lot numbers 05668 and AD47385) is illegal.

Image of the counterfeit Lilly Icos Cialis 20mg tablets inside the blister packsCounterfeit Lilly Icos Cialis 20mg tablets (Lot numbers 05668 and AD47385) 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

  • Stop taking counterfeit Lilly Icos Cialis 20mg tablets (Lot numbers 05668 and AD47385) 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.
  • No batches of genuine Eli Lilly and Company's Cialis 20mg tablets are affected and patients can continue to take as prescribed.

Action the TGA is taking

The TGA is working with Australian Customs and Border Protection Service (ACBPS) to help stop future shipments of counterfeit Lilly Icos Cialis 20mg 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