FDA Recall D-0577-2024

Little Moon Essentials LLC · Dania Beach, FL

Class II Ongoing 693 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: lot code no expiration date on product: a) 322230, 424040, b) 322230, 325070, 324080, 325180, 325280, 328290, 426110, 423210, 426120, 422220, 423130, 428230, 325040

Quantity: 320 metal tins

Reason for recall

CGMP deviations

Recall record

Recall number: D-0577-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA and Ontario, Canada (2 retailers)
Recall initiated: 2024-06-20
Classified by FDA Center: 2024-07-02
FDA published: 2024-07-10
Recalling firm: Little Moon Essentials LLC
Firm location: Dania Beach, FL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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