Vietnam to test Glaxo antibiotic for plasticizer

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The Drug Administration of Vietnam (DAV) has instructed its agencies to collect samples of Augmentin to test for plasticizer content after the substance was found in the GlaxoSmithKline's common antibiotic in Hong Kong.

 

DAV has also requested GlaxoSmithKline's office in Vietnam to coordinate with its distributors to collect Augmentin samples being sold in Vietnam for testing.

 

Test results are expected to be available by August 5, DAV said in a statement on Friday.

 

DAV said on July 22 that it had received information from Hong Kong authorities about the recall of 375mg Augmentin pills found with plasticizers di-2-ethyl hexyl phthalate (DEHP), the diisodecyl phthalate (DIDP), and the diisononyl phthalate (DINP).

 

In Vietnam, the license for the import of 375mg Augmentin pills expired in September 2001. A valid license is still available for importing the drug in other forms and strengths, including 625mg and 1000mg pills and 250mg and 500mg powder sachets.

 

In June, Hong Kong ordered GlaxoSmithKline Plc (GSK) to recall a pediatric antibiotic manufactured in France over the presence of a plasticizer in the product.

 

The Hong Kong Department of Health said in a statement that diisodecyl phthalate (DIDP) was detected in GSK's Augmentin powder for syrup 156mg/5ml, a product for children.

 

A government laboratory test found the presence of DIDP was two times higher than Europe's specific migration limit for food contact materials.

 

DIDP's safety for human consumption has not been well established, but data from animal studies suggest long-term consumption of high levels of DIDP may affect the liver.

 

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