Recall of three registered pharmaceutical products related to plasticiser incident

Published on: 2011-06-02 Hong Kong (HKSAR) - The Department of Health (DH) today (June 2) ordered the recall of three more registered pharmaceutical products imported from Taiwan as part of its continual follow-up action on the plasticiser incident in Taiwan. The recall order followed laboratory results from Government Laboratory received today, indicating the presence of Di(2-ethylhexyl) phthalate (DEHP) alone or together with Diisononyl phthalate (DINP) in three other products. The concerned products are Mebendazole Tab 100mg (Panbiotic) (Registration no. HK-53603), Oxo Cap 100mg (Registration no.  HK-34702) and Scoro Orabase 1mg/g Meider (Registration no. HK-59097). Laboratory results indicated that Mebendazole Tab 100mg (Panbiotic) was found to contain DEHP at a level of 2.2 ppm. It is for treating worm infections, manufactured by Panbiotic Laboratories, Taiwan and imported by Yat Seng Trading Co (Yat Seng). Yat Seng has set up a hotline 2687 6629 for public enquiries. The supplier of the flavouring agent is related to one of the incriminated suppliers in the Taiwan DEHP incident¡C Laboratory results indicated that Oxo Cap 100mg was found to contain DEHP at a level of 1.6 ppm. It is for treating respiratory tract inflammation, manufactured by Yung Shin Pharm Ind Co Ltd, Taiwan and imported by Yung Shin Co Ltd in Hong Kong (Yung Shin). Yung Shin has set up a hotline 2637 5131 to answer enquiries. The last product, Scoro Orabase 1mg/g Meider, which is oral gel for treating mouth ulcers, was found to contain DEHP at a level of 1.8 ppm and DINP at a level of 2.0 ppm. manufactured by Meider Pharm Co Ltd, Taiwan, imported by Wings Pharmaceutical Ltd and distributed by America Golden Rich Pharmaceuticals Ltd (Golden Rich). Golden Rich has set up a hotline 2673 4826 for the recall. Long term consumption of DEHP at high level may affect liver and kidney, and may cause cancer. DINP has similar chronic toxicity as DEHP. Concerning carcinogenicity, no relevant human data are available. The suppliers of the flavouring agents of the last two products are not related to the incriminated suppliers. The matter will be referred to Taiwan Food and Drug Administration for their information and further investigation. "DH will continue investigation and closely monitor the situation of plasticiser contamination in Taiwan," he said. He stressed that the levels of DEHP and DINP detected are considered unlikely to cause acute harmful effects if taken according to the recommended dosage.