FDA recall D-0104-2018

Gadget Island, Inc · Class I · drug

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.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2017-09-15
Report date
2017-12-13
Termination date
2018-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newark, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0104-2018