D-0579-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 27, 2016
- Initiation Date
- December 22, 2015
- Termination Date
- March 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 bottles
Product Description
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
Reason for Recall
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Distribution Pattern
Nationwide and to Guatemala and Canada.
Code Information
Lot: G9471