PlainRecalls
FDA Drug Moderate Class II Terminated

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, In

Reported: January 27, 2016 Initiated: December 22, 2015 #D-0579-2016

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

Details

Recalling Firm
Grato Holdings, Inc.
Units Affected
90 bottles
Distribution
Nationwide and to Guatemala and Canada.
Location
Woodbine, IA

Frequently Asked Questions

What product 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. Recalled by Grato Holdings, Inc.. Units affected: 90 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 27, 2016. Severity: Moderate. Recall number: D-0579-2016.

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