Home / Grato Holdings, Inc. / F-1402-2018
Class II
Grato Holdings, Inc.
Recall #F-1402-2018 · Initiated 2018-04-16
Plain-language summary
by FoodRecallsDB.infoWhat happened
The FDA determined that Peaceful Mountain Nasal Rescue, marketed as a dietary supplement for sinus support, is actually an unapproved drug because of health claims made about it. The company is recalling 27,860 bottles that were sold nationwide and in Canada.
Who is at risk
Anyone who purchased this product should be aware of the recall, though this is primarily a regulatory issue rather than a safety hazard.
What to do
Stop using this product and contact Peaceful Mountain, Inc. for a refund. You can also check the FDA's official recall website for more details about this product or contact your healthcare provider if you have questions about alternatives for sinus support.
Product
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, 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
27,860 1.5 oz bottles
Distribution
Shipped to customers nationwide and Canada.
Lot / code info
G9558, G9716, G10110, G10471
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 -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, I…