FDA recall D-0577-2016

Grato Holdings, Inc. · Class II · drug

Product

Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, 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-0577-2016