FDA Recall D-039-2013
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
Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066
Reason for recall
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Recall record
- Recall number
D-039-2013- 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