D-0573-2023 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2023
- Initiation Date
- April 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 140 blister packs
Product Description
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
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 Pattern
Nationwide in the USA.
Code Information
Lot/Item#: OMS760-B, Exp: 12/2025