Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G)...

FDA Recall #D-0577-2024 — Class II — June 20, 2024

Recall #D-0577-2024 Date: June 20, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

CGMP deviations

Recalling Firm

Little Moon Essentials LLC — Dania Beach, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

320 metal tins

Distribution

Nationwide USA and Ontario, Canada (2 retailers)

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated