Why it was 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.
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.
Lot numbers, UPCs & expiration codes
No Lot #: labeled Expires: 10-17-2018
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0032-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 22, 2017
- FDA report date
- Nov 1, 2017
- Quantity
- 75 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vitility
Original FDA data
Every field from FDA enforcement report D-0032-2018, exactly as published.
Show all FDA fields
- City
- Sacramento
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 77841
- Address
- 7283 Florin Mall Dr
- Address (line 2)
- Apt #3
- Code information
- No Lot #: labeled Expires: 10-17-2018
- Postal code
- 95823-2748
- Report date
- Nov 1, 2017
- Product type
- Drugs
- Recall number
- D-0032-2018
- Classification
- Class I
- Recalling firm
- Vitility
- Product quantity
- 75 packets
- Termination date
- Apr 24, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 22, 2017
- Initial firm notification
- Press Release
- Center classification date
- Oct 24, 2017