FDAFDA · Food and drugs·Recall number D-0032-2018
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.
Published November 1, 2017 · Recall initiated: June 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Vitility
- Distributor
- Nationwide in the USA
- Lot
- No Lot #: labeled Expires: 10-17-2018
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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