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Presence of foreign substance: Presence of Benzene.
Failed Dissolution Specifications
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Label declares tofu but it does not declare soy.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Undeclared allergen (milk)
Contains undeclared milk
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Chemical Contamination: Presence of benzene