Product: PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
Reason for recall: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recall initiated: 20170915
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated