Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911...
FDA Recall #D-0580-2016 — Class II — December 22, 2015
Product Description
Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Reason for Recall
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recalling Firm
Grato Holdings, Inc. — Woodbine, IA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
118 bottles
Distribution
Nationwide and to Guatemala and Canada.
Code Information
Lot: G9471
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated