# FDA recall D-038-2013

> **Coral Rock Man, Inc.** · Class I · drug recall initiated 2012-07-16.

## 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, FL,  Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida

## Reason for recall

Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

## Distribution

Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.

## Key facts

- **Recall number:** D-038-2013
- **Recalling firm:** Coral Rock Man, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-16
- **Report date:** 2012-11-07
- **Termination date:** 2015-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Key Colony Beach, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-038-2013

## Citation

> AI Analytics. FDA recall D-038-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-038-2013. Source: US FDA. Licensed CC0.

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