D-0574-2024Class 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

1264 glass jars

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP deviations

Product description

Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004

Code / lot info

lot code no expiration dates on product: a) 328260, 321221, 425120, 427230, b) 327150, 326260, 320270, 321301, 422020

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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.