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Potential presence of glass pieces
Product label includes the ingredient CREAM but does not include Milk as the source.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Undeclared wheat and milk from sub-ingredients.
Undeclared milk from Contains statement.
Undeclared wheat, milk, and soy (from soy lecithin) from sub-ingredients.