Online pharmacy Valisure has raised concerns about what it believes are risky levels of another probable carcinogen in valsartan, filing a citizen petition with the US Food and Drug Administration on 13 June requesting that the agency significantly lower the permitted daily exposure (PDE) limit of the residual solvent, called N-Dimethylformamide (DMF).
Further, the pharmacy wants manufacturers to recall lots of drugs where it found concerning levels of DMF impurities. In the meantime, the FDA has refused to budge, saying that the...