Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) ...
FDA Recall #D-0578-2016 — Class II — December 22, 2015
Product Description
Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, 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
371 bottles
Distribution
Nationwide and to Guatemala and Canada.
Code Information
Lot: G9471
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated