D-0288-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2018
- Initiation Date
- April 16, 2018
- Termination Date
- October 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 106,329 cards; b) 109,725 bottles; c) 28,644 bottles
Product Description
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.
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.
Distribution Pattern
Nationwide in the USA
Code Information
All lots