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Undeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Lack of Assurance of Sterility
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Undeclared sesame and wheat allergens
Undeclared wheat allergen
Undeclared wheat allergens
regular yeast was inadvertently packaged as nutritional yeast
Contains undeclared sulfites, undeclared FD&C Yellow 6, and unapproved color: Amaranth (E123).
Product contains undeclared sulfites.
CGMP Deviations