FDA Recall D-038-2013
Coral Rock Man, Inc. · Key Colony Beach, FL
Class I — life-threatening Terminated 1232 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-038-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
- Recall initiated
- 2012-07-16
- Classified by FDA Center
- 2012-11-01
- FDA published
- 2012-11-07
- Terminated
- 2015-11-30
- Recalling firm
- Coral Rock Man, Inc.
- Firm location
- Key Colony Beach, FL