Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Distributed: NationwideReason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Distributed: NationwideReason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Distributed: NationwideReason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Distributed: NationwideReason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Distributed: NationwideReason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Distributed: NationwideReason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Distributed: NationwideReason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Distributed: NationwideReason: Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Distributed: NationwideReason: Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Distributed: Nationwide