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Recalled drug:  Oxo Cap 100mg manufactured by Yung Shin in Taiwan was found to contain DEHP at a level of 1.6ppm.

Three drugs recalled due to plasticisers

June 02, 2011
The Department of Health today ordered the recall of three more registered pharmaceutical products imported from Taiwan because they were found to contain plasticisers.
 
The recall order followed Government Laboratory results received today, indicating the presence of Di(2-ethylhexyl) phthalate (DEHP) alone or together with Diisononyl phthalate (DINP).
 
The 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).
 
Lab results indicated that Mebendazole Tab 100mg (Panbiotic) was found to contain DEHP at a level of 2.2ppm. It is for treating worm infections, manufactured by Panbiotic Laboratories, Taiwan and imported by Yat Seng Trading Co which has set up an enquiry hotline, 2687 6629.
  
Test results indicated that Oxo Cap 100mg was found to contain DEHP at a level of 1.6ppm. 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's enquiry hotline is 2637 5131.
 
Scoro Orabase 1mg/g Meider, an oral gel for treating mouth ulcers, was found to contain DEHP at a level of 1.8ppm and DINP at a level of 2ppm. It is manufactured by Meider Pharm Co Ltd, Taiwan, imported by Wings Pharmaceutical Ltd, and distributed by America Golden Rich Pharmaceuticals Ltd. Golden Rich's hotline is 2673 4826.
 
Long-term consumption of DEHP at high levels may affect liver and kidneys, and may cause cancer. DINP has similar chronic toxicity as DEHP, but no human data is available concerning its carcinogenicity.
 
The department said the levels of the two substances detected are considered unlikely to cause acute harmful effects if taken according to the recommended dosage.
 
The matter will be referred to Taiwan Food & Drug Administration for information and further investigation.


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