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Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.
During an inspection by the FDA the firm was notified by FDA that the product contains contains wheat but the label states it is "Gluten Free".
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.