Why it was recalled
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Product description
X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
Lot numbers, UPCs & expiration codes
UPC 0 00309 50792 7 All Lots
Where it was sold
Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.
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-037-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 21, 2012
- FDA report date
- Nov 7, 2012
- Quantity
- 215,000 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- XRock Industries, LLC
Original FDA data
Every field from FDA enforcement report D-037-2013, exactly as published.
Show all FDA fields
- City
- Pompano Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 61669
- Address
- 571 Se 14th St
- Code information
- UPC 0 00309 50792 7 All Lots
- Postal code
- 33060-9315
- Report date
- Nov 7, 2012
- Product type
- Drugs
- Recall number
- D-037-2013
- Classification
- Class I
- Recalling firm
- XRock Industries, LLC
- Product quantity
- 215,000 capsules
- Termination date
- Nov 30, 2015
- Reason for recall
- Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
- Distribution pattern
- Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.
- Recall initiation date
- Apr 21, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 1, 2012