FDA Recall D-0032-2018
Vitility · Sacramento, CA
Class I — life-threatening Terminated 306 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; [email protected]; www.manofsteelpills.com; UPC 1 0001001378 7.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Recall record
- Recall number
D-0032-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2017-06-22
- Classified by FDA Center
- 2017-10-24
- FDA published
- 2017-11-01
- Terminated
- 2018-04-24
- Recalling firm
- Vitility
- Firm location
- Sacramento, CA