Drug product
Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
D-0577-2024
Product summary
- Event
- Event 94788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 320 metal tins
- Official record key
drug-enforcement:D-0577-2024
Official wording
Reason: CGMP deviations
Code information: lot code no expiration date on product: a) 322230, 424040, b) 322230, 325070, 324080, 325180, 325280, 328290, 426110, 423210, 426120, 422220, 423130, 428230, 325040
Distribution pattern: Nationwide USA and Ontario, Canada (2 retailers)
Derived failure modes
-
Manufacturing or process control
CGMP deviations