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Potential Listeria monocytogenes contamination.
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.