The Recall Desk

FDA (Drugs) recall action 65762

Myson Corporation, Inc. recalled 2 products on 2013-12-18

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
2013-12-18
Critical
1
Units
70

Why these products were recalled

Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • CriticalFDA (Drugs)··2013-12-18

    Volcano Male Enhancement Capsules Recalled for Undeclared Pharmaceutical Ingredients

    Myson Corporation is recalling Volcano Male Enhancement capsules because they contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.

    Product
    Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordycep
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2013-12-18

    Volcano Male Enhancement Liquid Recalled for Undeclared Pharmaceutical Ingredients

    Myson Corporation is recalling Volcano Male Enhancement Liquid because it contains undeclared active pharmaceutical ingredients, making it an unapproved new drug.

    Product
    Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.
    Category
    Distribution
    0 states