Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass j...

FDA Recall #D-0574-2024 — Class II — June 20, 2024

Recall #D-0574-2024 Date: June 20, 2024 Classification: Class II Status: Ongoing

Product Description

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

Recalling Firm

Little Moon Essentials LLC — Dania Beach, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1264 glass jars

Distribution

Nationwide USA and Ontario, Canada (2 retailers)

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated