FDA recall D-0685-2021

Product

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Reason for recall

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2021-03-29

Report date

2021-07-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Lee, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0685-2021