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