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Class II: temporary or reversible health riskTerminated

Grato Holdings Peaceful Mountain Recall

Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist

Grato Holdings, Inc. · Woodbine, IA

Risk level
Class II
Reported by FDA
May 16, 2018
Recall ID
F-1402-2018
Check your lot numberHow we source this data

Summary

Grato Holdings recalled Peaceful Mountain starting Apr 16, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1402-2018 on May 16, 2018. Reason: Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

G9558, G9716, G10110, G10471

Where it was sold

Shipped to customers nationwide and Canada.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1402-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 16, 2018
FDA report date
May 16, 2018
Quantity
27,860 1.5 oz bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Grato Holdings, Inc.

Original FDA data

Every field from FDA enforcement report F-1402-2018, exactly as published.

Show all FDA fields
City
Woodbine
State
IA
Status
Terminated
Country
United States
Event ID
79774
Address
201 Apple Blvd
Code information
G9558, G9716, G10110, G10471
Postal code
51579-1503
Report date
May 16, 2018
Product type
Food
Recall number
F-1402-2018
Classification
Class II
Recalling firm
Grato Holdings, Inc.
Product quantity
27,860 1.5 oz bottles
Termination date
Aug 17, 2018
Reason for recall
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Distribution pattern
Shipped to customers nationwide and Canada.
Recall initiation date
Apr 16, 2018
Initial firm notification
Letter
Center classification date
May 9, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1402-2018, published May 16, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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