Why it was recalled
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
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
Lot numbers, UPCs & expiration codes
All Lots All codes.
Where it was sold
Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-038-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 16, 2012
- FDA report date
- Nov 7, 2012
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Coral Rock Man, Inc.
Original FDA data
Every field from FDA enforcement report D-038-2013, exactly as published.
Show all FDA fields
- City
- Key Colony Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62543
- Address
- 420 11th Street
- Code information
- All Lots All codes.
- Postal code
- 33051
- Report date
- Nov 7, 2012
- Product type
- Drugs
- Recall number
- D-038-2013
- Classification
- Class I
- Recalling firm
- Coral Rock Man, Inc.
- Product quantity
- unknown
- Termination date
- Nov 30, 2015
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
- Recall initiation date
- Jul 16, 2012
- Initial firm notification
- Telephone
- Center classification date
- Nov 1, 2012