Drug 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
D-038-2013
Product summary
- Event
- Event 62543
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-038-2013
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.