Gold Cross Codeine Linctus APF

TGA consumer safety advisory

15 October 2009

The Therapeutic Goods Administration advises that Gold Cross Codeine Linctus APF, a prescription medicine cough suppressant, is being recalled from retail shelves because the medicine does not have the required child resistant closure. The manufacturer, Biotech Pharmaceuticals Pty Ltd, is undertaking the recall.

The quality and effectiveness of Gold Cross Codeine Linctus APF is not affected by the lack of a child resistant closure.

What consumers need to do

  • This medicine presents a serious risk if taken by children.
  • This medicine must be kept out of reach of children at all times.
  • If you have any queries or wish to return the product please call Biotech Pharmaceuticals on 1800 620 898.

What retailers need to do

If you have stock of Gold Cross Codeine Linctus APF you should:

  • Follow the advice received from Biotech Pharmaceuticals Pty Ltd which includes:
    • Quarantine stock
    • Complete and return the fax reply form sent to you from Biotech Pharmaceuticals
    • Send the stock back to the wholesaler by 30 October 2009

Advertising of the recall is expected to appear in national daily newspapers from 14 October 2009.

About the Therapeutic Goods Administration (TGA)

  • The TGA is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
  • TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance).
  • The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
  • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
  • To report a problem with a medicine or medical device, please see information on the TGA website: Report a problem.