X-ROCK For Men Recalled for Unapproved Prescription Drug Ingredients
XRock Industries is recalling X-ROCK For Men dietary supplements because testing revealed the presence of unapproved prescription drug ingredients.
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
XRock Industries, LLC is recalling 215,000 capsules of X-ROCK For Men dietary supplements. The product was manufactured by CRM Laboratories and distributed nationwide and internationally to Australia, the Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, the U.S. Virgin Islands, Jamaica, and the United Kingdom.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing indicated that the product contained PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, which is an FDA-approved prescription drug used to treat erectile dysfunction.
Consumers who have purchased X-ROCK For Men should stop using the product and contact the recalling firm for further instructions. The affected product can be identified by the UPC 0 00309 50792 7.
The recalled product
- Product
- X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
- Manufacturer
- XRock Industries, LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 215,000
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 (1)
- UPC 0 00309 50792 7 All Lots
Distribution
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