FDA recall D-0105-2018

Gadget Island, Inc · Class I · drug

Product

FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056

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-0105-2018