TGA recalls potentially unsafe eye drops

Media release

2 September 2004

Australia's medicines watchdog, the Therapeutic Goods Administration (TGA), has ordered a consumer level recall of an over the counter eye drop following spot checks by the TGA of the safety of eye drops in the market place picked up safety concerns with Eye-Lite Eye Drops, manufactured in Switzerland.

The TGA's initial tests indicated that the product was not likely to meet the required preservative efficacy test and the Australian sponsor, Apisant Pty. Ltd, was instructed not to supply any further product pending the completion of testing.

The TGA laboratories in Canberra have now confirmed that the product does not meet the required preservative efficacy standards and there is, therefore, the potential for bacteria to develop in the eye drops.

This means that if the product is contaminated during use - for example, from touching the dropper or putting down the cap - microorganisms may grow in the drops which could lead to infection in the eye when the drops are next used.

Some eye infections can be serious in people using contact lenses and the Eye-Lite Eye Drops are specifically recommended for use in people with contact lenses.

Consumers who may have the product in their home should not use the drops and either dispose of them safely or return them to the place of purchase for a refund.

The company was required to run recall advertisements in metropolitan newspapers today under TGA supervision.

Media contact: Kay McNiece, Media Adviser, 0412 132 585