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Zero Count Adds Up To 70,000-Bottle Ranitidine Recall For AuroMedics

Executive Summary

Additional recent recalls include 19,000 bottles of product marketed by Fitoterapia USA and labeled as liquid vitamin C but found to contain erectile dysfunction drug taldalafil .Ongoing testing of ranitidine drugs by FDA and manufacturers led to Aurobindo Pharma USA recall of one lot of OTC 150-mg tablets.

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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.

EMA Tells Firms To Evaluate OTCs For Carcinogenic Nitrosamines

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.

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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