Food recall

Grato Holdings, Inc. recall: Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg

Grato Holdings, Inc., of Woodbine, IA, recalled Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg and 3 other products. The FDA's reason: “Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on April 16, 2018, and the FDA first listed it in its Enforcement Report of May 16, 2018. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed August 17, 2018

The recall

Company
Grato Holdings, Inc. (Woodbine, IA)
Reason, in FDA's words
“Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.”
Where it was sold
Shipped to customers nationwide and Canada.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
79774

The 4 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1400-2018 Class II

    Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579

    Codes: G9525, G9706, G9980, G10419, G10641

    Quantity: 32,213 4 oz packages

  • F-1401-2018 Class II

    Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579

    Codes: J20597, J20840, J21846, J21849, J21850, J23464, J23465, J23466, J23467

    Quantity: 845 1-oz bottles, 59 1-oz bottles

  • F-1402-2018 Class II

    Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579

    Codes: G9558, G9716, G10110, G10471

    Quantity: 27,860 1.5 oz bottles

  • F-1403-2018 Class II

    Energique, Dietary Supplement, Enervimin CNCR Focus, Dist. by Energique Inc.. Woodbine, IA 51579

    Codes: 50070340, 55837004

    Quantity: 767 120-tablet bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of May 16, 2018.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.