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Registration Cancelled For Three (3) Traditional Products
The public is advised to avoid buying and using three (3) traditional products namely Mistura Zhike, Chi Kat Pills dan Herbaios-Zuekertec Capsule which has been detected containing adulterants as follows:-
No | Produk Name | Marketing Authorization Holder | Manufacturer | Analysis Result |
---|---|---|---|---|
1 | Mistura Zhike (MAL08042248T) | Metro Signature Sdn. Bhd., Selangor. | Guangzhou Pangaoshou Pharmaceutical Co. Ltd., China | Ephedrine and pseudoephedrine detected |
2 | Chi Kat Pills (MAL07090990T) | Nature Pack Enterprise, Kuala Lumpur. | Nature Pack Enterprise, Kuala Lumpur. | Ephedrine detected |
3 | Herbaios-Zuekertec Capsule(MAL08091522T) | Sinar Aman Pharmaceutical (M) Sdn. Bhd., Selangor. | Sinar Aman Pharmaceutical (M) Sdn. Bhd., Selangor. | Glibenclamide and metformin detected |
The registration for the listed products has been cancelled by the Drug Control Authority (DCA) at its 240th meeting on 26 May 2011 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.
Ephedrine and/or pseudoephedrine are controlled medicines often found as decongestants in cold medicines. Their usage at therapeutic doses prescribed by healthcare professionals provide benefit to patients, but if used indiscriminately without proper diagnosis and supervision, it can cause serious adverse events such as hypertension, psychiatric-related symptoms such as hallucination, schizophrenia, delusion and even risk of getting stroke if taken on prolonged use. Ephedrine and/or pseudoephedrine are not allowed in traditional products and if taken, can be harmful to consumers who are at high risk of getting these adverse events as well as patients with underlying heart disease, hypertension and hyperthyroidism.
Metformin and/or glibenclamide are controlled medicines used for the treatment of diabetes. Their usage without proper diagnosis and monitoring by healthcare professionals can cause serious adverse events such as hypoglycemia (excessive reduction in blood sugar). Symptoms of hypoglycaemia include dizziness, tremor, sweating, confusion and lethargy. Severe hypoglycaemia may lead to convulsion, unconsciousness or coma. Metformin and/or glibenclamide are not allowed in traditional products. Hence, these products can cause detrimental effects to consumers who are at high risk of getting these adverse events and diabetic patients on treatment.
The public is advised to stop using these products and they can seek further advice from healthcare professionals, if needed.
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.
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