Drug Enforcement D-0575-2024

CGMP deviations

Status

Ongoing

Classification

Class II

Report Date

July 10, 2024

Termination Date

Product Information

Product description
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
Product quantity
1041
Reason for recall
CGMP deviations
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide USA and Ontario, Canada (2 retailers)

Location & Firm

Recalling firm
Little Moon Essentials LLC
Address
501 Old Griffin Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0575-2024
Event ID
94788
Recall initiation date
June 20, 2024
Center classification date
July 2, 2024
Code info
lot code no expiration date on product: a) 324280, b) 328230, 321170, 321290, 326021, 420220, 422140, c) 326040, 328170
More code info