Recall D-0573-2023
Description: DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Recall D-0573-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0573-2023 |
Event ID | 92203 |
Distribution | Nationwide in the USA. |
Quantity | 140 blister packs |
Recall Reason | 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. |
Drug Classification | Class I |
Drug Code Info | 20230510 |
Recall Initiation Date | 20230426 |
Report Date | 20230510 |
Classification Date | 20230511 |
Address | 1275 Halyard Dr Ste 175 West Sacramento, CA 95691 United States |
Recalling Firm | Gadget Island, Inc |
Initial Notification | Letter |
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