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DeLauro Renews Push To Give FDA Mandatory Recall Authority For Drugs

Executive Summary

"FDA’s failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer," says Rep. DeLauro in letter to FDA and HHS. She also re-introduced legislation proposing FDA have mandatory recall authority for drugs.

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FDA Finds Ranitidine Poses Little Risk, But Concerns Linger

Ranitidine no more carcinogenic than grilled meat, says FDA drug center director Janet Woodcock. Agency finds NDMA levels in ranitidine drugs well below those claimed by Valisure, online pharmacy asking FDA to order drug off US market.

Contamination In Common OTC Antacid Adds To FDA's API Impurity Concerns

FDA assessing contamination of Rx and OTC H2 blocker ranitidine to determine steps it should take. The contaminant, NDMA, is dangerous when consumed in large quantities, but has been found in H2 blockers at levels that don't pose a risk, FDA says.

Online Pharmacy Stirs Ranitidine Controversy With Petition To Halt Sales

After its tests showed ranitidine forms a nitrosamine impurity that is a probable carcinogen, Valisure asks FDA to suspend sales of antacid products containing the API. In citizen petition firm, online pharmacy also advises FDA to publish regulations requiring independent chemical testing, verification of drugs.

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