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Recall Observatory FDA recall evidence

Food product

Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579

F-1402-2018

April 16, 2018

Class II

Product summary

Firm
Grato Holdings, Inc.
Event
Event 79774
Status
Terminated
Classification
Class II
Quantity
27,860 1.5 oz bottles
Official record key
food-enforcement:F-1402-2018

Official wording

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

Code information: G9558, G9716, G10110, G10471

Distribution pattern: Shipped to customers nationwide and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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