Peaceful Mountain Stomach Rescue Recalled as Unapproved New Drug
Grato Holdings is recalling Peaceful Mountain Stomach Rescue dietary supplements because they are unapproved new drugs based on disease claims.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving unapproved drugs or significant regulatory violations, even without explicit reports of hospitalization in the provided text.
Plain-English summary
Grato Holdings, Inc. is recalling Peaceful Mountain Stomach Rescue dietary supplements. The product contains elemental silver (45 ppm) and is distributed by Peaceful Mountain, Inc. in Woodbine, Iowa. The recall involves 32,213 4-ounce packages.
The FDA has determined that the product is an unapproved new drug because it is marketed with disease claims or routes of administration that require approval. The agency has classified this recall as Class II, meaning there is a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The affected products were shipped to customers nationwide and in Canada. Consumers should check their inventory for the specific product name and lot codes G9525, G9706, G9980, G10419, or G10641. If you have this product, you should stop using it and contact the recalling firm for instructions on how to return it or dispose of it safely.
The recalled product
- Product
- Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- G9525
- G9706
- G9980
- G10419
- G10641
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Grato Holdings, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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