Home / Grato Holdings, Inc. / F-1400-2018
Class II
Grato Holdings, Inc.
Recall #F-1400-2018 · Initiated 2018-04-16
Plain-language summary
by FoodRecallsDB.infoWhat happened
Peaceful Mountain Stomach Rescue dietary supplement was recalled because it was marketed with medical claims that made it an unapproved drug under FDA rules, rather than a properly regulated dietary supplement. The product contains elemental silver and was distributed nationwide and in Canada.
Who is at risk
Anyone who purchased and used this product should be aware of this recall.
What to do
Stop using Peaceful Mountain Stomach Rescue and contact the manufacturer or your retailer for a refund. If you have health concerns after using this product, consult your doctor.
Product
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Reason for recall
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Quantity affected
32,213 4 oz packages
Distribution
Shipped to customers nationwide and Canada.
Lot / code info
G9525, G9706, G9980, G10419, G10641
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Terminated
2018-08-17
Recalling firm
Grato Holdings, Inc.
201 Apple Blvd
Woodbine, IA 51579-1503
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.
Other recalls from Grato Holdings, Inc.
Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml) bottle.
BioActive Nutritional MINAPLEX, Botanical Herbal Supplement; 1 Fl. oz. (30 ml) bottle.
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, I…