FDA Drug Recalls

Recalls / Class II

Class IID-0573-2024

Product

Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004

Affected lot / code info
lot code No expiration date on product: a) 326070, 420140, b) 322030, 321230, 329230, 321240, 329170, 328280, 326090, 322290, 327021, 323121, 327221, 429210, 424130, 427050

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
6,312 tin and 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-0573-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls