Dithrasal ointment

Consumer level recall

6 April 2009

DITHRASAL 1% (dithranol 10mg/g) ointment 50g tube
AUST R 15561
Batch number: 6A49
Expiry Date: July 2009

and

DITHRASAL 2% (dithranol 20mg/g) ointment 50g tube
AUST R 15562
Batch number: 34526
Expiry Date: March 2011

Dermatech Laboratories Pty Ltd, following consultation with the Therapeutic Goods Administration (TGA), is recalling to consumer level affected batches of Dithrasal Ointment. The ointment, used for treatment of sub acute and chronic psoriasis of the scalp and body is sold through pharmacies in 50 gram tubes.

These batches of the product are being recalled because they contain higher than permitted levels of 1, 8 dihydroxyanthraquinone (DHAQ).

DHAQ is a known breakdown product of dithranol (the active ingredient in Dithrasal) and is permitted in the product at low levels. High levels of DHAQ have been associated with the development of tumours in animal studies.

While epidemiological studies have not demonstrated an association between DHAQ and the development of tumours in humans, the product is being recalled as a precaution to avoid any potential safety risk to consumers.

If you have purchased the affected product, you are advised to stop using it and contact your GP or dermatologist for ongoing treatment options.

Consumers who have concerns over their use of the product, should consult their medical practitioner.

Press advertising of the Recall is expected to appear in state daily newspapers commencing Monday 6 April 2009.

Media Contact: Kay McNiece, TGA, 0412 132 585