PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
Recall Number: D-0104-2018
Firm: Gadget Island, Inc
Classification: Class I
Status: Terminated
Report Date: 20171213
Initiation Date: 20170915
Termination Date: 20181204
Reason for Recall
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Product Description
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587