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The Quality Control Unit has failed to investigate an impurity Out-of-Specification for Methscopolamine Nitrate lots 313001N09 and 313001N10, manufactured on 8/12/09 and 4/12/10, respectively. The(b) (4) specification for Methscopolamine Nitrate is no single impurity is greater (b) (4) An unknown impurity was detected on lots 313001N09 and 31300IN10 a(b) (4), respectively.