D-039-2013 Class I Terminated
FDA drug recall D-039-2013 was initiated by Coral Rock Man, Inc. on July 16, 2012 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. The recall status is terminated (terminated November 30, 2015). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- November 7, 2012
- Initiation Date
- July 16, 2012
- Termination Date
- November 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
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.
Distribution Pattern
Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
Code Information
All Lots All codes.