Cancellation Of Registration Of Traditional Product Sta-lions

The public is advised to avoid buying and using traditional product Sta-lions with registration number MAL08091457TC following cancellation of its registration by the Drug Control Authority (DCA) at its 262nd meeting on 28th March 2013 due to the detection of scheduled poison tadalafil. The registration holder for this product is Together Link Enterprise, Pulau Pinang and the manufacturer is DZ Trade (Malaysia) Sdn. Bhd., Kedah. The indication printed on the product label specified it as traditionally used for general health.

Tadalafil is used to treat erectile dysfunction (ED) or impotence and can only be supplied by doctors or be obtained at pharmacies upon prescription. Usage of tadalafil without proper diagnosis and monitoring by doctor may cause serious adverse events such as decreased or loss of vision and hearing, lowering of blood pressure to dangerous level and cardiovascular events such as stroke and heart attack (myocardial infarction). Tadalafil or its analogues are not allowed to be formulated in any product classified as traditional product. Therefore, this product may potentially cause detrimental effects especially to those who are at higher risk of developing such adverse events like heart patients (angina pectoris) receiving nitrates.  

Consumers are advised to stop using Sta-lions and they shall seek further advice from healthcare professionals, if experiencing any unpleasant effects or adverse events. Consumers may contact the National Pharmaceutical Control Bureau at 03-78835546/5539 or email bpfk@bpfk.gov.my for further enquiry or information.

Anyone who is in possession of this product 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 of the Sale of Drugs Act 1952. 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.

DATUK DR NOOR HISHAM ABDULLAH
Director General of Health Malaysia
(Chairman of Drug Control Authority)

Putrajaya