D-0685-2021 Class I Ongoing

Recalled by Nuri Trading LLC — Fort Lee, NJ

Recall Details

Product Type
Drugs
Report Date
July 28, 2021
Initiation Date
March 29, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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 Pattern

USA Nationwide

Code Information

all lots within expiry