Recalls / Class II
Class IIF-1400-2018
Product
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
- Type
- Food
- Affected lot / code info
- G9525, G9706, G9980, G10419, G10641
- Quantity
- 32,213 4 oz packages
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-1400-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings.