Recalls / Class II

Class IID-0575-2024

Product

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

Affected lot / code info

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

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

1041

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-0575-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.