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Grato Holdings, Inc. Recall: Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. - F-1400-2018

United States

TerminatedClass II

Company
Grato Holdings, Inc.
Product
Peaceful Mountain -Stomach Rescue - Dietary supplement - Ele…
Recall date
April 16, 2018
Terminated
August 17, 2018
Source
FDA

Reason for recall

Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579 Not published in this source record 32,213 4 oz packages G9525, G9706, G9980, G10419, G10641

Distribution

  • Shipped to customers nationwide and Canada.

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1400-2018
Event ID
79774
Status
Terminated
Classification
Class II
Company
Grato Holdings, Inc.
Product description
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Quantity
32,213 4 oz packages
Reason
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Recall initiation date
April 16, 2018
Report date
May 16, 2018
Classification date
Not published in this source record
Termination date
August 17, 2018
Distribution pattern
Shipped to customers nationwide and Canada.
UPC, lot, and code information
G9525, G9706, G9980, G10419, G10641
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Letter
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Other products recalled under this same event

This recall shares FDA event ID 79774 with 3 other product entries in Public Health Trace.

FDA Recall United States TerminatedTerminated: August 17, 2018Historical recordClass II

Grato Holdings, Inc.

Product
Energique, Dietary Supplement, Enervimin CNCR Focus, Dist.…
Published
May 16, 2018
Distribution
Nationwide

View recall →

FDA Recall United States TerminatedTerminated: August 17, 2018Historical recordClass II

Grato Holdings, Inc.

Product
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural…
Published
May 16, 2018
Distribution
Nationwide

View recall →

FDA Recall United States TerminatedTerminated: August 17, 2018Historical recordClass II

Grato Holdings, Inc.

Product
Energique, Herbal Supplement, Octocom,; Dist. by Energique,…
Published
May 16, 2018
Distribution
Nationwide

View recall →

Responsible company: Grato Holdings, Inc.

Other recalls from Grato Holdings, Inc.

FDA Recall United States TerminatedTerminated: July 5, 2024Historical recordClass II

Grato Holdings, Inc.

Product
BioActive Nutritional MINAPLEX, Botanical Herbal Supplement;…
Published
July 10, 2024
Distribution
Nationwide

View recall →

FDA Recall United States TerminatedTerminated: July 5, 2024Historical recordClass II

Grato Holdings, Inc.

Product
Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml)…
Published
July 10, 2024
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: May 12, 2024Historical recordClass III

V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935

by Grato Holdings, Inc.

Published
November 15, 2023
Distribution
Distributed to one direct account in Flo…

View recall →

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

FDA classifies this recall as Class II. See how to read an FDA recall record (linked above) for what each classification level means.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.

Official guidance and record verification

Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.

How to interpret this historical record

This record is preserved as published by FDA, as of August 17, 2018.

Status as reported: Terminated.

This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.

View the official FDA source

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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