FDA Recall D-0288-2019
Epic Products, LLC · Overland Park, KS
Class I — life-threatening Terminated 2362 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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.
Recall record
- Recall number
D-0288-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-04-16
- Classified by FDA Center
- 2018-11-30
- FDA published
- 2018-11-21
- Terminated
- 2024-10-03
- Recalling firm
- Epic Products, LLC
- Firm location
- Overland Park, KS