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Recall Observatory FDA recall evidence

Drug product

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

D-0685-2021

March 29, 2021

Class I

Product summary

Firm
Nuri Trading LLC
Event
Event 87641
Status
Ongoing
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0685-2021

Official wording

Reason: 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.

Code information: all lots within expiry

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.