FDA recall D-0574-2024

Little Moon Essentials LLC · Class II · drug

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

Reason for recall

CGMP deviations

Distribution

Nationwide USA and Ontario, Canada (2 retailers)

Key facts

Status
Ongoing
Initiation date
2024-06-20
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dania Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2024