Mucokehl 'i' 5 mL liquid solution

Safety advisory - do not use in the eye

15 October 2014

Consumers and health professionals are advised that Mucokehl 'i' 5 mL liquid solution does not meet Australian quality requirements and could cause an infection if applied to a person's eye.

Mucokehl 'i' 5 mL liquid solution is a homeopathic product that has been marketed for use in the eye. The fact that it is sold in 5 mL packages implies that the product is intended to be multi-dose, rather than single-use.

Investigations by the TGA have found that Mucokehl 'i' 5 mL liquid solution does not meet the required Microbiological Standards for Medicines. Specifically, the product is not effectively preserved to reduce Candida albicans and Aspergillus brasiliensis fungal species, which is required in Australia for multi-dose medicines.

Products that are intended for use in the eye must be included on the Australian Register of Therapeutic Goods as registered medicines after undergoing assessment for safety, quality and efficacy. They are also required to display certain information on the label in relation to use in the eye. Mucokehl 'i' 5 mL liquid solution does not comply with these requirements.

Information for consumers

If you have Mucokehl 'i' 5 mL liquid solution, do not apply it to your eyes. The solution is not adequately preserved and could cause an infection if used.

If you have any questions or concerns about this issue, talk to a health professional.

Information for health professionals

TGA investigations have found that, due to failing preservative efficacy testing, using Mucokehl 'i' 5 mL liquid solution in the eye carries a risk of fungal keratitis.

If you are aware that a patient you are treating is using this product, inform them of the above issue and advise them to not apply it to their eyes.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.