Drug product
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
D-0574-2024
Product summary
- Event
- Event 94788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1264 glass jars
- Official record key
drug-enforcement:D-0574-2024
Official wording
Reason: CGMP deviations
Code information: lot code no expiration dates on product: a) 328260, 321221, 425120, 427230, b) 327150, 326260, 320270, 321301, 422020
Distribution pattern: Nationwide USA and Ontario, Canada (2 retailers)
Derived failure modes
-
Manufacturing or process control
CGMP deviations