Oh Baby! Natural Formula capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000mg capsules
Published 25 August 2017
Product
Male herbal supplements All lots are affected
Why it was 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.
Hazard
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.