D-0104-2018 Class I Terminated

Recalled by Gadget Island, Inc — Newark, CA

Recall Details

Product Type
Drugs
Report Date
December 13, 2017
Initiation Date
September 15, 2017
Termination Date
December 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
89 1-capsule packets

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot# NSS050888, EXP 05-2018