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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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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