Drug product
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
D-0572-2024
Product summary
- Event
- Event 94788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 788 glass jars
- Official record key
drug-enforcement:D-0572-2024
Official wording
Reason: CGMP deviations
Code information: lot code No Expiration Date on product: a) 224010, b) 321260, 322260, 320280, 328080, 325021, 321121, 423010, 427110, 429120, 420220, 422140
Distribution pattern: Nationwide USA and Ontario, Canada (2 retailers)
Derived failure modes
-
Manufacturing or process control
CGMP deviations