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Sale Of Unregistered Product: Jcare-su And Jcare-in
The public is advised to avoid buying and using two (2) traditional products namely ‘JCare-su’ with registration number MAL07090966TC and ‘JCare-in’ with registration number MAL07124653TC which has been detected containing glibenclamide. Indication printed on labels is traditionally used for general health and improving blood circulation. The product registration holder for both products is Usaha Kiara Sdn. Bhd., Kuala Lumpur and the manufacturer is Len Fa Medical Supplies (M) Sdn. Bhd., Selangor.
The product registration for ‘JCare-su’ and ‘JCare-in’ has been cancelled by the Drug Control Authority (DCA) at its 237th meeting following the detection of scheduled poison, Glibenclamide. Glibenclamide is a controlled medicine for diabetic patients and is not allowed to be formulated in a product which is classified as a traditional product.
Glibenclamide can only be supplied by doctors or available at pharmacies upon a prescription. The usage of glibenclamide without proper diagnosis and monitoring by the doctor 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. Hence, these products can cause detrimental effects to consumers who are diabetic and who are at high risk of getting these adverse events.
The public is advised to stop using it and they can seek further advice from healthcare professionals, if needed.
Anyone who is in possession 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.
Dato' Dr Hasan bin Abdul Rahman
Director General of Health Malaysia
As DCA Chairman
Ministry of Health Malaysia