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Recall Observatory FDA recall evidence

Drug product

Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3

D-0642-2021

April 08, 2021

Class I

Product summary

Firm
NSNY Distributor Inc
Event
Event 87712
Status
Ongoing
Classification
Class I
Quantity
399 capsules
Official record key
drug-enforcement:D-0642-2021

Official wording

Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

Code information: all lots

Distribution pattern: USA Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil