Drug Enforcement D-0344-2024

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product 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
SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Product quantity
11500 boxes
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product 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-0344-2024
Event ID
93941
Recall initiation date
February 6, 2024
Center classification date
February 22, 2024
Code info
Lot #: 2108, Exp. Date 10/31/2024.
More code info
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