The Recall Desk
ModerateFDA (Drugs)·D-0579-2016·Announced 2016-01-27

Energique Headache Spray Recalled for Microbial Contamination

Grato Holdings is recalling Energique Headache Pain & Sinus Pressure Relief Topical Spray due to microbial contamination.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination of a non-sterile product without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Grato Holdings, Inc. is recalling 90 bottles of Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles. The product is also labeled as Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray. The affected lot number is G9471.

The recall was initiated because testing revealed out-of-specification results for total aerobic microbiological count, indicating microbial contamination of the non-sterile product. The agency classifies this recall as Class II.

The product was distributed nationwide and to Guatemala and Canada. Consumers should stop using the product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
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
Manufacturer
Grato Holdings, Inc.
Category
Drug — Homeopathic Remedy
Hazard
Affected units
90

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: G9471

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Grato Holdings, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Grato Holdings, Inc.

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Same hazard · microbial contamination

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