FDA Recall D-0472-2017
MS Bionic · Gardena, CA
Class I — life-threatening Terminated 183 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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)
Recall record
- Recall number
D-0472-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- CA
- Recall initiated
- 2016-11-30
- Classified by FDA Center
- 2017-02-13
- FDA published
- 2017-02-22
- Terminated
- 2017-06-01
- Recalling firm
- MS Bionic
- Firm location
- Gardena, CA