FDA recall D-0575-2016

Grato Holdings, Inc. · Class II · drug

Product

Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, 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-0575-2016