FDAFDA · Food and drugs·Recall number D-038-2013
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
Published November 7, 2012 · Recall initiated: July 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Coral Rock Man, Inc.
- Distributor
- Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
- Lot
- All Lots All codes.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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