Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mou...

FDA Recall #F-1402-2018 — Class II — April 16, 2018

Recall #F-1402-2018 Date: April 16, 2018 Classification: Class II Status: Terminated

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.

Recalling Firm

Grato Holdings, Inc. — Woodbine, IA

Classification

Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Product Type

Food

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated