Erectile dysfunction pills marketed as "herbal" and "all-natural" have been recalled by Medsafe after tests found they contained a prescription ingredient that can be fatal.
Four products – SZM Formula for Men, Volcanic, Tomcat Ali and Stallion – have been recalled and the Health Ministry said consumers should stop taking any of the pills.
Tests showed that, although the capsule contents were all herbal ingredients, the capsule shells contained high levels of tadalafil – the active ingredient in prescription erectile dysfunction drug Cialis.
Tadalafil can interfere with some heart medications and using it in such cases can be harmful or even fatal.
The Health Ministry was not aware of any adverse reactions to the products.
The Medicines Act requires medicines to be approved by Medsafe before they are sold in New Zealand. Breaching the requirement carries a fine of up to $20,000 or six months' prison for individuals, and a maximum penalty of $100,000 for companies.
Medsafe estimates that hundreds of thousands of the capsules have been sold in pharmacies, health stores, adult shops and over the internet during the past two years.
Medsafe principal clinical adviser Enver Yousuf said the drug watchdog had become suspicious of the products after hearing reports of how effective they were.
Last year, Medsafe's Singapore counterpart discovered that some "rogue" manufacturers were adding active ingredients to capsule shells – which until now had not been tested.
"It was clear that the active ingredients were being added to the capsule shells in order to evade detection," Dr Yousuf said.
Medsafe would now test the capsule shells of other suspicious products.
SZM Formula NZ, which imports and markets SZM Formula for Men and Stallion, denied any knowledge that the capsule shells contained tadalafil. "The capsules are made in China," sales manager Ken Ringin said.
"It's been quite a shock – we're pretty angry with the suppliers of the product."
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