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Boxed Warnings and Precautions Initial labeling for Xarelto, as a part of its FDA approval in 2011, included two black box warnings. Black box warnings indicate that the drug could cause particularly dangerous side effects

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31 , 110 In June 2021, Pfizer Pharmaceuticals voluntarily recalled varenicline tablets because some batches were found to contain a nitrosamine impurity (N-nitroso-varenicline) at levels above FDAs acceptable intake limit

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