FDA Recall United States Terminated Historical recordClass II
Grato Holdings, Inc.
- Product
- Energique, Dietary Supplement, Enervimin CNCR Focus, Dist.…
- Published
- May 16, 2018
- Distribution
- Nationwide
Grato Holdings, Inc. Recall: Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
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.
- - Recall initiated
- - Reported by source
- - Recall terminated
| 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 Terminated Historical recordClass II
Grato Holdings, Inc.
- Product
- Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural…
- Published
- May 16, 2018
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Grato Holdings, Inc.
- Product
- Energique, Herbal Supplement, Octocom,; Dist. by Energique,…
- Published
- May 16, 2018
- Distribution
- Nationwide
Responsible company: Grato Holdings, Inc.
Other recalls from Grato Holdings, Inc.
FDA Recall United States Terminated Historical recordClass II
Grato Holdings, Inc.
- Product
- BioActive Nutritional MINAPLEX, Botanical Herbal Supplement;…
- Published
- July 10, 2024
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Grato Holdings, Inc.
- Product
- Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml)…
- Published
- July 10, 2024
- Distribution
- Nationwide
FDA Recall Terminated Historical 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
- Published
- November 15, 2023
- Distribution
- Distributed to one direct account in Flo…
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
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?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
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 instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
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.
