Publication of Notification and Recovery of Therapeutic Goods - LOVher Herbal Viagra for Her capsules

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

PUBLICATION OF NOTIFICATION AND RECOVERY OF THERAPEUTIC GOODS, SECTION 30EA OF THE THERAPEUTIC GOODS ACT 1989

I, Pio Cesarin, delegate of the Secretary to the Department of Health for the purposes of section 30EB of the Therapeutic Goods Act 1989 (the Act), hereby publish particulars of the my decision under section 30EA of the Act to undertake public notification and recovery of LOVher Herbal Viagra for Her capsules and require Mr Raymond Walter Thorpe, Director and Secretary, Happy Herb Company Pty Ltd to:

1. Take steps to recover to consumer level any of the goods that have been distributed in Australia;
2. Within 7 days put arrangement into place to publish a notice in a prominent position on the home page of  the www.happyherbcompany.com website to the effect that:

• LOVher, for HER, Herbal Viagra capsules pose a risk to your health and safety and should not be taken. You should stop taking LOVher, for HER, Herbal Viagra capsules and take any remaining capsules to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.
• The Therapeutic Goods Administration has tested LOVher, for HER, Herbal Viagra capsules and found that they contain the undisclosed prescription-only substances tadalafil and sildenafil and also contain diclofenac, a non-steroidal anti-inflammatory ingredient used in pharmacy only and prescription only medicines.
• LOVher, for HER, Herbal Viagra capsules have not been assessed by the TGA for quality, safety or efficacy as required by the TGA, these capsules should not have been supplied.
• TGA investigations have shown that a number of people in Australia may have bought the product online and / or in store.

3.       The notice should appear on the website for at least 30 days.

(Signed by)

Pio Cesarin

Head, Office of Parliamentary and Strategic Support

Therapeutic Goods Administration

(Delegate of the Secretary to the Department of Health).

28 March 2014.