M Distribution - male herbal supplements

Consumers, retailers and health professionals are advised that M Distribution, in consultation with the TGA, has initiated a recall of Oh Baby! capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000 mg capsules as they contain substances that cannot be supplied without a prescription.

Results of TGA testing of these products included:

• Oh Baby! capsules - tadalafil was detected
• JO LMax Extra tablets - the presence of the labelled ingredient dimethylaminoethanol (DMAE or Deanol) was confirmed
• RUFF Natural Formula 10,000 mg capsules - tadalafil, sildenafil and dapoxetine were detected.

Consumers and retailers are advised that dapoxetine, tadalafil, sildenafil and deanol are Prescription Only Medicines in Australia. The supply of any herbal capsules containing undisclosed dapoxetine, tadalafil or sildenafil is illegal. Deanol is a Prescription Only Medicine and while the product was labelled as containing deanol, supply without a valid prescription is also illegal in Australia.

Oh Baby! capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000 mg capsules have been illegally supplied in Australia, as they are not listed on the Australian Register of Therapeutic Goods (ARTG) and, as such, have not been assessed by the TGA for quality, safety or efficacy, as required under Australian law. Also, the place of manufacture has not been approved by the TGA.

Information for consumers and retailers

If you have any Oh Baby! capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000 mg capsules stop taking them or supplying them.

Consumers should return affected products to the place of purchase for a refund. Retailers should contact M Distribution on 07 5522 1950 to arrange return of the affected product.

If you have any questions or concerns arising from your use of these male supplements, contact your health professional.

Information for health professionals

Please be alert to this issue. Advise consumers not to take the affected supplements and to return them to the place of purchase for a refund.

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.