Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Reported: July 28, 2021 Initiated: March 29, 2021 #D-0685-2021
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.
Details
- Recalling Firm
- Nuri Trading LLC
- Units Affected
- N/A
- Distribution
- USA Nationwide
- Location
- Fort Lee, NJ
Frequently Asked Questions
What product was recalled? ▼
Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC. Recalled by Nuri Trading LLC. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 28, 2021. Severity: Critical. Recall number: D-0685-2021.
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