FDA orders withdrawal of ranitidine drug from markets
India, April 2 -- US drug regulator completes seven-month investigation, finds high levels of carcinogen
The US Food and Drug Administration (FDA) has found "unacceptable levels" of a cancer- causing agent in ranitidine drugs and has ordered for its immediate withdrawal from the country's markets.
The impurity of the contaminant, namely, N-Nitrosodimethylamine (NDMA), in ranitidine medications (commonly known by the brand name Zantac) increases over time, especially when stored at higher than room temperatures, the FDA said in a statement on April 1, 2020.
"It may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for ne...
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