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Australia Suspends 23 Ranitdine Products Contaminated with NDMA

Executive Summary

A six-month suspension from sale has been handed to 23 ranitidine drugs sold in Australia. The country's regulator has suggested all 23 are facing a permanent ban over patient safety fears.

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

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. 

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Firms operating in the EU given six months to evaluate all OTC drugs containing chemically synthesized APIs for presence of nitrosamines, a probable human carcinogen. The order from EMA comes with a review of ranitidine underway after nitrosamine NDMA was detected in a number of OTC and Rx drugs.

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