The Recall Desk

FDA (Drugs) recall action 62543

Coral Rock Man, Inc. recalled 2 products on 2012-11-07

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-11-07
Critical
2
Units
—

Why these products were recalled

Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • CriticalFDA (Drugs)··2012-11-07

    FDA Recalls Unapproved X-Rock 3 Day Pill For Men

    Coral Rock Man, Inc. is recalling X-Rock 3 Day Pill For Men because the product was marketed without an approved NDA/ANDA and tested positive for Sildenafil and analogs.

    Product
    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, F
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2012-11-07

    Z-ROCK Male Supplement Recalled for Unapproved Sildenafil Content

    Coral Rock Man, Inc. is recalling Z-ROCK All Natural Male Supplement because testing revealed the presence of Sildenafil and its analogs, which were not approved in the product.

    Product
    Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066
    Category
    Distribution
    0 states