Pharmacy Urges US FDA To Disallow Levels Of DMF Solvent It Found In Valsartan

The saga of tainted valsartan has taken another turn with an online pharmacy that tests its medications before dispensing them finding yet another probable carcinogen in lots of the blood pressure medication from multiple manufacturers. The pharmacy filed a citizen petition asking the US FDA to tighten its globally harmonized limit for the residual solvent.  

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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

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