Recalls / Class II

Class IID-0574-2024

Product

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

Affected lot / code info

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

Why it was recalled

CGMP deviations

Recalling firm

Firm

Little Moon Essentials LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

501 Old Griffin Rd, N/A, Dania Beach, Florida 33004-2774

Distribution

Quantity

1264 glass jars

Distribution pattern

Nationwide USA and Ontario, Canada (2 retailers)

Timeline

Recall initiated

2024-06-20

FDA classified

2024-07-02

Posted by FDA

2024-07-10

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0574-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.