D-0577-2024Class II

Little Moon Essentials LLC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-07-10

Distribution

Nationwide USA and Ontario, Canada (2 retailers)

Firm state

Product quantity

320 metal tins

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP deviations

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

Code / lot info

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

Other recalls SPEQ maps to Risk Management & CAPA

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See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.