Grato Holdings, Inc. recalls Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911…

Recall date

December 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0579-2016

FDA classification

Class II

Brand / firm

Grato Holdings, Inc.

Sold / distributed

Nationwide and to Guatemala and Canada.

Why it was recalled

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA