D-0685-2021 Class I Ongoing
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