FDA Recalls Unapproved X-Rock 3 Day Pill For Men
Coral Rock Man, Inc. is recalling X-Rock 3 Day Pill For Men because the product was marketed without an approved NDA/ANDA and tested positive for Sildenafil and analogs.
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
Coral Rock Man, Inc. is recalling X-Rock 3 Day Pill For Men, which is supplied in 1 and 2 capsule blister packs and 6, 12, and 24 count bottles. The product is distributed by MATE Enterprises in Miami, Florida, and some units are labeled as manufactured by CRM Laboratories and distributed by XRock Industries in Ft. Lauderdale, Florida. Other labels identify the product as X-Rock 3 Day Pill For Erectile Refunction, distributed by www.CoralXRock.Com in the Florida Keys, Florida.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Laboratory testing revealed that the product tested positive for Sildenafil and analogs of Sildenafil. The recall covers all lots and all codes.
The product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales. Consumers who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, F
- Manufacturer
- Coral Rock Man, Inc.
- Category
- Drug — Unapproved Supplement
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)
- All Lots All codes.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Coral Rock Man, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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