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Recall Observatory FDA recall evidence

Drug product

Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA

D-0580-2016

December 22, 2015

Class II

Product summary

Firm
Grato Holdings, Inc.
Event
Event 72891
Status
Terminated
Classification
Class II
Quantity
118 bottles
Official record key
drug-enforcement:D-0580-2016

Official wording

Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Code information: Lot: G9471

Distribution pattern: Nationwide and to Guatemala and Canada.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification