FDA Recalls Energique Homeopathic Skin Spray Due to Microbial Contamination
Grato Holdings, Inc. is recalling 118 bottles of Energique homeopathic skin 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 agency classified this as an FDA Class II recall involving microbial contamination, which meets the rubric criteria for a Severe severity score.
Plain-English summary
Grato Holdings, Inc. is recalling 118 bottles of Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle. The product is also labeled as Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, and peaceful mountain, skin irritant & healing support, homeopathic spray. The recall involves Lot 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 recall as Class II.
The affected products were distributed nationwide and to Guatemala and Canada. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist…
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Topical Homeopathic
- 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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