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Australia Finds ‘Unacceptable’ Levels Of NDMA In 80% of Ranitidine Batches

 
• By Tom Gallen

Testing carried out by Australia's drug agency on batches of 34 ranitidine products marketed by 10 different sponsors has found high levels of NDMA contamination in the vast majority of cases. The agency is now considering tightening its oversight of all ranitidine drugs sold in Australia. 

Drugs question mark

Australia’s Therapeutic Goods Administration says the levels of potential carcinogen N-nitrosodimethylamine (NDMA) its testing has identified in ranitidine heartburn remedies are “unacceptable” leading the agency to withdraw numerous products from sale.

Prompted by US Food and Drug Administration and European Medicines Agency warnings about potential ranitidine contamination in September, the TGA tested 135 batch samples of ranitidine drugs (from 34 products) sold in Australia by 10 different sponsors

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