Why it was recalled
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Product description
Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
Lot numbers, UPCs & expiration codes
None
Where it was sold
Utah
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-266-2013
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 10, 2012
- FDA report date
- Apr 24, 2013
- Quantity
- 50,000 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Menz Club, LLC
Original FDA data
Every field from FDA enforcement report D-266-2013, exactly as published.
Show all FDA fields
- City
- Ridgeland
- State
- MS
- Status
- Ongoing
- Country
- United States
- Event ID
- 63684
- Address
- 103 W. Washington Street
- Address (line 2)
- Suite B5
- Code information
- None
- Postal code
- 39157
- Report date
- Apr 24, 2013
- Product type
- Drugs
- Recall number
- D-266-2013
- Classification
- Class I
- Recalling firm
- The Menz Club, LLC
- Product quantity
- 50,000 capsules
- Reason for recall
- Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
- Distribution pattern
- Utah
- Recall initiation date
- Mar 10, 2012
- Initial firm notification
- Center classification date
- Apr 18, 2013