D-037-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 7, 2012
- Initiation Date
- April 21, 2012
- Termination Date
- November 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215,000 capsules
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.
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).
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.
Code Information
UPC 0 00309 50792 7 All Lots