FDA Recalls V Maxx Rx Male Enhancement Product for Unapproved Drug Content
The Menz Club, LLC is recalling V Maxx Rx because FDA testing found it contains an unapproved drug analogue.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
The Menz Club, LLC is recalling V Maxx Rx, All Natural Male Enhancement, in 1-count, 5-count, and 10-count packages. The recall involves 585,000 capsules distributed nationwide.
The FDA is recalling this product because samples tested by the agency were found to contain sulfoaildenafil. Sulfoaildenafil is an analogue of sildenafil, an FDA-approved drug used to treat male erectile dysfunction. The presence of this substance makes the product an unapproved new drug that was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased V Maxx Rx should stop using the product and contact the manufacturer for a refund or further information.
The recalled product
- Product
- 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:
- Manufacturer
- The Menz Club, LLC
- Category
- Drug — Unapproved New Drug
- Affected units
- 585,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #s: a) 101108
- 101009
- 101010
- 101011
- b) 101108
- 101109
- 101110
- c) 301000
- 301001
Distribution
Distributed nationwide across the United States.
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