PUTRAJAYA – Two metformin products which have been recalled from the market by its manufacturer, Marksans Pharma Limited, are not registered in Malaysia and not supplied to the health facilities in the country.
Senior Director of Pharmaceutical Services Datin Dr Faridah Aryani Md Yusof said only metformin products registered with the Drug Control Authority (DCA) are allowed to be supplied to diabetic patients in the country.
“A total of 68 metformin products registered with the DCA and available in the Malaysian market, have undergone the N-Nitrosodimethylamine (NDMA) impurity testing.
“Metformin products currently in the market do not contain NDMA and do not exceed the NDMA impurity limit,” she said in a media statement Oct 14.
Dr Faridah Aryani said the ministry’s National Pharmaceutical Regulatory Agency (NPRA) would recall the metformin products from the market if they have NDMA impurities that exceed the limit.
According to the International Agency for Research on Cancer (IARC), prolonged exposure to higher levels of NDMA can increase the risk of developing cancer.
On Oct 9, CNN Health reported that two metformin products used for diabetic patients were recalled after manufacturers found it contained unacceptably high levels of a cancer-causing agent and the NDMA had exceeded the internationally acceptable level.
The recalled products are Metformin Hydrochloride Extended-Release Tablets USP 500mg and Metformin Hydrochloride Extended-Release Tablets USP 750mg.
“The MOH constantly conducts continuous monitoring through registered product quality monitoring programmes and pharmacovigilance to ensure the quality, safety and effectiveness of medicines are always guaranteed.
“The MOH will inform the public of the latest developments from time to time,” she said.