February 2024 FDA Recall Drug by Fa Online Inc
D-0470-2024 - Marketed Without an Approved NDA/ANDA
This Class I drug recall was voluntarily initiated by Fa Online Inc on February 12, 2024 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0470-2024
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.
02-12-2024
05-01-2024
400 capsules
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
FA Online Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide. The product was sold via Amazon Market Place.
06-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Batch or Lot Expiration Information
Lot# All lots within expiry
