Drug product
Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
D-0573-2024
Product summary
- Event
- Event 94788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,312 tin and glass jars
- Official record key
drug-enforcement:D-0573-2024
Official wording
Reason: CGMP deviations
Code information: lot code No expiration date on product: a) 326070, 420140, b) 322030, 321230, 329230, 321240, 329170, 328280, 326090, 322290, 327021, 323121, 327221, 429210, 424130, 427050
Distribution pattern: Nationwide USA and Ontario, Canada (2 retailers)
Derived failure modes
-
Manufacturing or process control
CGMP deviations