Little Moon Essentials Asana Kisser Drug Recalled Due to CGMP Deviations
Little Moon Essentials Asana Kisser, a topical product containing camphor and menthol, is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 320 units distributed in the United States and Canada.
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: This is a voluntary, firm-initiated FDA Class II recall with no reported illnesses or injuries. The hazard is process-related rather than an identified contamination or specific safety issue, consistent with precautionary recalls.
Plain-English summary
Little Moon Essentials LLC is recalling Asana Kisser, a topical drug product containing 1.35% camphor and 2.86% menthol, due to deviations from Current Good Manufacturing Practice (CGMP) standards. The product is sold in two sizes: 0.5 OZ (14G) metal tins and 3 OZ (85G) metal tins with multiple lot codes.
The recall affects approximately 320 metal tins distributed nationwide in the United States and Ontario, Canada through retailers. The manufacturer, Little Moon Essentials LLC located in Dania Beach, Florida, voluntarily initiated this recall on June 20, 2024.
Consumers who have purchased this product should stop using it and contact the manufacturer or their retailer for instructions on return or disposal.
The recalled product
- Product
- Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
- Manufacturer
- Little Moon Essentials LLC
- Category
- Drug — Topical / Lip Product
- Affected units
- 320
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 (15)
- lot code no expiration date on product: a) 322230
- 424040
- b) 322230
- 325070
- 324080
- 325180
- 325280
- 328290
- 426110
- 423210
- 426120
- 422220
- 423130
- 428230
- 325040
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Little Moon Essentials LLC 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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