D-0472-2017 Class I Terminated

Recalled by MS Bionic — Gardena, CA

Recall Details

Product Type
Drugs
Report Date
February 22, 2017
Initiation Date
November 30, 2016
Termination Date
June 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 bottles

Product Description

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 Pattern

CA

Code Information

All Lots exp. date 12/2019