D-0575-2024Class 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

1041

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP deviations

Product description

Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004

Code / lot info

lot code no expiration date on product: a) 324280, b) 328230, 321170, 321290, 326021, 420220, 422140, c) 326040, 328170

Other recalls SPEQ maps to Risk Management & CAPA

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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.