D-0572-2024Class 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

788 glass jars

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP deviations

Product description

Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004

Code / lot info

lot code No Expiration Date on product: a) 224010, b) 321260, 322260, 320280, 328080, 325021, 321121, 423010, 427110, 429120, 420220, 422140

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.