PRA number
2017/16281
Published date
Product description
Male herbal supplements
All lots are affected
All lots are affected
Reasons the product is recalled
Results of testing by the Therapeutic Goods Administration (TGA) showed that these products contained substances that cannot be supplied without a prescription.
- Samples of Oh Baby! capsules were tested and found to contain tadalafil.
- Samples of JO LMax Extra tablets were tested and found to contain dimethylaminoethanol (DMAE or Deanol).
- Samples of RUFF Natural Formula 10,000mg capsules were tested and found to contain tadalafil, sildenafil and dapoxetine.
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.
The hazards to consumers
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.
What consumers should do
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.
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.
Supplier
M Distribution Pty Ltd
Traders who sold this product
Adult stores and online
Where the product was sold
Nationally
Online
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.