HSA Alerts Public to Illegal Product 'AMACE for him' Found to Contain Undeclared Chemical Ingredient

The Health Sciences Authority (HSA) is alerting members of the public not to consume an illegal product ‘AMACE for him’ as it was tested to contain a potent undeclared chemical ingredient, N-cyclopentyl nortadalfil. N-cyclopentyl nortadalfil is an analogue (a chemically-related compound) of tadalafil, a prescription medicine which is used in the treatment of male impotence, and may cause serious adverse effects. These include headaches, dizziness, high blood pressure, chest pain and muscle aches. In addition, tadalafil and its analogues should not be used by patients with certain medical conditions, including heart problems, or patients who are taking heart medications such as nitrates as fatalities have been reported. 

2     Although HSA has not yet received any adverse reaction reports associated with ‘AMACE for him”, this does not mean that the product does not cause any harm. Persons taking the product may not link the adverse effects they experienced with the product or share with their doctors that they are taking such a product. Consumers should be aware that illegal health products are generally produced under poor manufacturing conditions with no quality control, and the contents of the product can vary from batch to batch, which can pose serious health hazards. 

3     ‘AMACE for him’ was sold locally by Acupoint Pte Ltd located at Balestier Plaza. The product claimed to be a health supplement containing only natural ingredients, including lingzhi, ginseng, cordyceps and wolfberry. ‘AMACE for him’ was marketed to ‘enhance energy level and blood circulation’ as well as ‘strengthen immune system for general well-being’ and claims to ‘arouse the sexual nerves’. The company has since stopped all sales of the product as instructed by HSA.  Please refer to Annex A for pictures of the product. 

4     While investigations are still ongoing, HSA has instructed Acupoint Pte Ltd to recall the product. HSA will take strong enforcement actions against individuals who engage in the sale and supply of health products containing undeclared potent medicinal ingredients. Anyone found to contravene the Poisons Act faces a penalty of up to $10,000 and/or imprisonment for a period of up to two years.   

Consumer Advisory

5     Members of the public are advised on the following: 

I. Stop consuming any remaining supplies of ‘AMACE for him’ immediately. Those who have taken the product should seek medical attention if they are feeling unwell or are concerned about their health. Undeclared potent ingredients may cause possible adverse reactions as well as drug interactions with other medications which can seriously harm your health.

II. Be wary of complementary health products (e.g. traditional medicines, health supplements) making exaggerated claims or promising ‘miraculous cures' and/or providing rapid relief of their medical conditions, such as male impotence and erectile dysfunction. 

III. Seek proper medical treatment for acute and chronic medical symptoms and conditions and do not self-medicate.  

IV. Contact Acupoint Pte Ltd at Tel: 68227789 should you have any enquiries on the recall. 

6     Members of the public who have any information on the sale of ‘AMACE for him’ or other illegal products may contact HSA's Enforcement Branch at Tel: 6866-3485 during office hours (Monday to Friday) or email: hsa_is@hsa.gov.sg. 

HEALTH SCIENCES AUTHORITY
SINGAPORE
8 OCTOBER 2014

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Published: 8 Oct 2014

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