FDA recall D-0288-2019

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-04-16

Report date

2018-11-21

Termination date

2024-10-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Overland Park, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2019