April 2018 FDA Recall Drug by Epic Products, Llc
D-0288-2019 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Epic Products, Llc on April 16, 2018 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-0288-2019

Reason for Recall
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
Initiated
04-16-2018
Reported
11-21-2018
Quantity
a) 106,329 cards; b) 109,725 bottles; c) 28,644 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79842
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Epic Products, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-03-2024
Product Description About Product Description
Full technical description of the product.
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.

Batch or Lot Expiration Information

Lot# All lots