Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579

FDA Recall #F-1401-2018 — Class II — April 16, 2018

Recall #F-1401-2018 Date: April 16, 2018 Classification: Class II Status: Terminated

Product Description

Energique, Herbal Supplement, Octocom,; Dist. by Energique, 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