N-nitroso-duloxetine has been linked to a higher risk ... can be related to the drug's manufacturing process or its chemical structure or even the conditions in which they are stored or packaged ...

and was set as a "class II" risk level by the FDA on Dec. 5. The medication was recalled due to the "presence of N-nitroso-duloxetine impurity above [the] recommended interim limit," the FDA said.