D-1657-2012 Class I Terminated
FDA drug recall D-1657-2012 was initiated by The Menz Club, LLC on May 25, 2012 and is designated Class I. 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, … The recall status is terminated (terminated December 7, 2015). Affected quantity: 585,000 Capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- August 29, 2012
- Initiation Date
- May 25, 2012
- Termination Date
- December 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 585,000 Capsules
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
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.
Distribution Pattern
Nationwide
Code Information
Lot #s: a) 101108, 101009, 101010, 101011; b) 101108, 101109, 101110; c) 301000, 301001