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Recall Observatory FDA recall evidence

Drug product

Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada

D-0343-2024

February 06, 2024

Class I

Product summary

Firm
Today The World
Event
Event 93941
Status
Ongoing
Classification
Class I
Quantity
7000 boxes
Official record key
drug-enforcement:D-0343-2024

Official wording

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.

Code information: Lot #: BTH:230551, Exp. Date 12.05.2026; BTH:230571, Exp. Date 14.05.2026

Distribution pattern: Product distributed nationwide within the United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.