Status
Terminated
Drug Enforcement D-038-2013
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Classification
Class I
Report Date
November 7, 2012
Termination Date
November 30, 2015
Product Information
- Product description
- 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
- Product quantity
- unknown
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
Location & Firm
- Recalling firm
- Coral Rock Man, Inc.
- Address
-
420 11th Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-038-2013
- Event ID
- 62543
- Recall initiation date
- July 16, 2012
- Center classification date
- November 1, 2012
- Code info
- All Lots All codes.
- More code info
- —