Recalls / Class II
Class IIF-1402-2018
Product
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
- Type
- Food
- Affected lot / code info
- G9558, G9716, G10110, G10471
- Quantity
- 27,860 1.5 oz bottles
Why it was recalled
Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration.
Recalling firm
- Firm
- Grato Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Apple Blvd, N/A, Woodbine, Iowa 51579-1503
Distribution
- Distribution pattern
- Shipped to customers nationwide and Canada.
Timeline
- Recall initiated
- 2018-04-16
- FDA classified
- 2018-05-09
- Posted by FDA
- 2018-05-16
- Terminated
- 2018-08-17
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1402-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings.