FDA recall D-0578-2016

Product

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

Distribution

Nationwide and to Guatemala and Canada.

Key facts

Status

Terminated

Initiation date

2015-12-22

Report date

2016-01-27

Termination date

2017-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woodbine, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0578-2016