F-1402-2018 Class II Terminated
FDA food recall F-1402-2018 was initiated by Grato Holdings, Inc. on April 16, 2018 and is designated Class II. Reason for recall: Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. The recall status is terminated (terminated August 17, 2018). Affected quantity: 27,860 1.5 oz bottles.
Recall Details
- Product Type
- Food
- Report Date
- May 16, 2018
- Initiation Date
- April 16, 2018
- Termination Date
- August 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,860 1.5 oz bottles
Product Description
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, 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 Pattern
Shipped to customers nationwide and Canada.
Code Information
G9558, G9716, G10110, G10471