Drug Enforcement D-0343-2024

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.

Status

Ongoing

Classification

Class I

Report Date

February 28, 2024

Termination Date

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Product Information

Product description
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Product quantity
7000 boxes
Reason for recall
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.
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Product distributed nationwide within the United States.

Location & Firm

Recalling firm
Today The World
Address
1954 NE Glisan St # 405, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0343-2024
Event ID
93941
Recall initiation date
February 6, 2024
Center classification date
February 22, 2024
Code info
Lot #: BTH:230551, Exp. Date 12.05.2026; BTH:230571, Exp. Date 14.05.2026
More code info
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