Registration of Two (2) Products Cancelled

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PRESS RELEASE
REGISTRATION OF TWO (2) TRADITIONAL PRODUCTS CANCELLED

The public is advised to avoid buying and using two (2) registered traditional products namely Kapsul Benkwat Ginseng Plus 500 mg (MAL07031076T) and JT Cordyceps Mycelium (MAL09080820T) which has been detected containing adulterants.  Kapsul Benkwat Ginseng Plus 500 mg has been detected to contain yohimbine, while JT Cordyceps Mycelium has been detected to contain thiodimethylsildenafil

The registration of both products has been cancelled by the Drug Control Authority (DCA) at its 252nd meeting on 31 May 2012 following the detection of scheduled poisons in the products which are not allowed to be formulated in a product which is classified as a traditional product.

Yohimbine is an alkaloid found usually in a plant known as Puasinystalia yohimbe which has been used for treatment of erectile dysfunction. Yohimbine is not allowed to be formulated in a product which is classified as a traditional product. Uncontrolled usage of yohimbine can cause serious adverse events such as high blood pressure, rapid heart rate, anxiety, insomnia, hallucination and manic reactions. Hence, this product can cause detrimental effects to consumers who are at high risk of getting these adverse events, particularly in pregnant women, people with high blood pressure, heart, kidney or liver disease.

Thiodimethylsildenafil is an analogue of sildenafil and is not allowed to be formulated in a product which is classified as a traditional product. The analogue has similar effect with sildenafil, which is used to treat erectile dysfunction. Their usage without proper diagnosis and monitoring by a doctor can cause serious adverse events such as decreased or loss of vision and hearing, may lower blood pressure to dangerous levels and cardiovascular events such as stroke and myocardial infarction. Hence, this product can cause detrimental effects to consumers who are at high risk of getting these adverse events, particularly angina patients receiving nitrates.

Consumers are advised to stop using both these products and they can seek further advice from healthcare professionals, if experiencing any unpleasant or adverse events. Consumers can contact NPCB at 03-78835546/8545 or email bpfk@bpfk.gov.my for further enquiry or information.

Anyone who is in possession any of these products is advised to immediately cease selling, distributing or using it. Sellers are reminded that possession for sale of these products is an offence under the Control of Drugs and Cosmetics Regulations 1984. Any individual who commits an offence under these regulations can be fined up to a maximum of RM25,000 or a jail sentence not exceeding 3 years or both for the first offence, and for a subsequent offence, a fine up to a maximum of RM50,000 or a jail sentence not exceeding 5 years or both. A company found guilty can be fined up to RM50,000 for the first offence and fined up to a maximum of RM100,000 for a subsequent offence.

Products that has been cancelled its registration due to adulteration

Kapsul Benkwat Ginseng Plus 500 mg

Product Name:
Kapsul Benkwat Ginseng Plus 500 mg
 
Registration No.:
MAL07031076T
 
Indication:
Traditionally used for energy, to strengthen the muscle and for vitality
 
Registration Holder:
Air Mancur International Sdn. Bhd., Kuala Lumpur
 
Manufacturer:
Pt. Air Mancur, Indonesia
 
Adulterant detected:
Yohimbine

 

JT Cordyceps Mycelium

Product Name:
JT Cordyceps Mycelium
 
Registration No.:
MAL09080820T
 
Indication:
Traditionally used for health and strengthening the body
 
Registration Holder:
Jin Teik Organic Health Food Sdn.Bhd., Kedah
 
Manufacturer:
Jin Teik Organic Health Food Sdn.Bhd., Kedah
 
Adulterant detected:
Thiodimethylsildenafil