FDA Recalls Energique Homeopathic Pain Spray for Microbial Contamination
Grato Holdings is recalling Energique First Aid Pain & Trauma Relief homeopathic spray due to out-of-specification microbial counts.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination, which meets the rubric criteria for a Severe rating (Score 4) due to the potential for significant health risks associated with contaminated medical products.
Plain-English summary
Grato Holdings, Inc. is recalling 118 bottles of Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles. The product is also labeled as Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray. The specific 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 has classified this as a Class II recall.
The affected products were distributed nationwide as well as to Guatemala and Canada. Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- 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…
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Homeopathic Remedy
- Hazard
- Affected units
- 118
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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