ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Summary
The FDA issued a Class I for ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-coun by FA Online Inc. Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatm.
Details
Source
Drug Recall
External ID
D-0470-2024
Action Date
2024-05-01
Status
Terminated
Category
drug
Product Description
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Lot/Code Info: All lots within expiry
Quantity Affected: 400 capsules
Reason for Recall
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Distribution
USA Nationwide. The product was sold via Amazon Market Place.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-12
Company
Fresh Meadows, NY
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 96 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (FA Online Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FA Online Inc have FDA actions?
This is the only FDA action we have on record for FA Online Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0470-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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