Drug product
MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.
D-0032-2018
Product summary
- Firm
- Vitility
- Event
- Event 77841
- Status
- Terminated
- Classification
- Class I
- Quantity
- 75 packets
- Official record key
drug-enforcement:D-0032-2018
Official wording
Reason: 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.
Code information: No Lot #: labeled Expires: 10-17-2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.