Drug 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
D-0575-2024
Product summary
- Event
- Event 94788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1041
- Official record key
drug-enforcement:D-0575-2024
Official wording
Reason: CGMP deviations
Code information: lot code no expiration date on product: a) 324280, b) 328230, 321170, 321290, 326021, 420220, 422140, c) 326040, 328170
Distribution pattern: Nationwide USA and Ontario, Canada (2 retailers)
Derived failure modes
-
Manufacturing or process control
CGMP deviations