Drug 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
D-039-2013
Product summary
- Event
- Event 62543
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-039-2013
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Code information: All Lots All codes.
Distribution pattern: Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.