D-0032-2018 Class I Terminated
FDA drug recall D-0032-2018 was initiated by Vitility on June 22, 2017 and is designated Class I. 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 … The recall status is terminated (terminated April 24, 2018). Affected quantity: 75 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- November 1, 2017
- Initiation Date
- June 22, 2017
- Termination Date
- April 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 packets
Product Description
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.
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.
Distribution Pattern
Nationwide in the USA
Code Information
No Lot #: labeled Expires: 10-17-2018