Class I
Ongoing
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
- Company
- Gadget Island, Inc
- Recall Initiated
- April 26, 2023
- Posted
- May 10, 2023
- Recall Number
- D-0573-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 140 blister packs
- Firm Location
- West Sacramento, CA, United States
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.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot/Item#: OMS760-B, Exp: 12/2025
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