Drug Enforcement D-0573-2023

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

Status

Ongoing

Classification

Class I

Report Date

May 10, 2023

Termination Date

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Product Information

Product description
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Product quantity
140 blister packs
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Gadget Island, Inc
Address
1275 Halyard Dr Ste 175

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0573-2023
Event ID
92203
Recall initiation date
April 26, 2023
Center classification date
May 11, 2023
Code info
Lot/Item#: OMS760-B, Exp: 12/2025
More code info
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