DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Summary
The FDA issued a Class I for DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 by Gadget Island, Inc. Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA app.
Details
Source
Drug Recall
External ID
D-0573-2023
Action Date
2023-05-10
Status
Ongoing
Category
drug
Product Description
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Lot/Code Info: Lot/Item#: OMS760-B, Exp: 12/2025
Quantity Affected: 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.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-26
Company
West Sacramento, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Gadget Island, Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gadget Island, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gadget Island, Inc have FDA actions?
Gadget Island, Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0573-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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