Why it was recalled
Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
Product description
V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746
Lot numbers, UPCs & expiration codes
Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001
Where it was sold
Nationwide
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-1657-2012
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 25, 2012
- FDA report date
- Aug 29, 2012
- Quantity
- 585,000 Capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Menz Club, LLC
Original FDA data
Every field from FDA enforcement report D-1657-2012, exactly as published.
Show all FDA fields
- City
- Ridgeland
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 61957
- Address
- 103 W. Washington Street
- Address (line 2)
- Suite B5
- Code information
- Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001
- Postal code
- 39157
- Report date
- Aug 29, 2012
- Product type
- Drugs
- Recall number
- D-1657-2012
- Classification
- Class I
- Recalling firm
- The Menz Club, LLC
- Product quantity
- 585,000 Capsules
- Termination date
- Dec 7, 2015
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746
- Distribution pattern
- Nationwide
- Recall initiation date
- May 25, 2012
- Initial firm notification
- Press Release
- Center classification date
- Aug 20, 2012