FDA recall F-1400-2018

Grato Holdings, Inc. · Class II · food

Product

Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; 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.

Distribution

Shipped to customers nationwide and Canada.

Key facts

Status
Terminated
Initiation date
2018-04-16
Report date
2018-05-16
Termination date
2018-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woodbine, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1400-2018