PlainRecalls
FDA Drug Critical Class I Terminated

PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587

Reported: December 13, 2017 Initiated: September 15, 2017 #D-0104-2018

Product Description

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.

Details

Recalling Firm
Gadget Island, Inc
Units Affected
89 1-capsule packets
Distribution
Nationwide in the USA
Location
Newark, CA

Frequently Asked Questions

What product was recalled?
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587. Recalled by Gadget Island, Inc. Units affected: 89 1-capsule packets.
Why was this product recalled?
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 13, 2017. Severity: Critical. Recall number: D-0104-2018.