Energique Headache Spray Recalled for Microbial Contamination
Grato Holdings is recalling Energique Headache Pain & Sinus Pressure Relief Topical Spray due to microbial contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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