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Class I: serious health riskOngoing

The Menz Club Blue Male Enhancement Pill Recall

Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS

The Menz Club, LLC · Ridgeland, MS

Risk level
Class I
Reported by FDA
Apr 24, 2013
Recall ID
D-266-2013
Check your lot numberHow we source this data

Summary

The Menz Club recalled Blue Male Enhancement Pill starting Mar 10, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-266-2013 on Apr 24, 2013. Reason: 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. Status: Ongoing.

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
E-Mail
Center classification date
Apr 18, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-266-2013, published Apr 24, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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