FDA recall D-0472-2017

MS Bionic · Class I · drug

Product

MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA

Reason for recall

Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)

Distribution

CA

Key facts

Status
Terminated
Initiation date
2016-11-30
Report date
2017-02-22
Termination date
2017-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gardena, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2017