PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: November 1, 2017 Initiated: June 22, 2017 #D-0032-2018

Product Description

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.

Details

Recalling Firm
Vitility
Units Affected
75 packets
Distribution
Nationwide in the USA
Location
Sacramento, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Vitility. Units affected: 75 packets.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 1, 2017. Severity: Critical. Recall number: D-0032-2018.