Why it was recalled
CGMP deviations
Product description
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
Lot numbers, UPCs & expiration codes
lot code no expiration dates on product: a) 328260, 321221, 425120, 427230, b) 327150, 326260, 320270, 321301, 422020
Where it was sold
Nationwide USA and Ontario, Canada (2 retailers)
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0574-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 20, 2024
- FDA report date
- Jul 10, 2024
- Quantity
- 1264 glass jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Little Moon Essentials LLC
Original FDA data
Every field from FDA enforcement report D-0574-2024, exactly as published.
Show all FDA fields
- City
- Dania Beach
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 94788
- Address
- 501 Old Griffin Rd
- Code information
- lot code no expiration dates on product: a) 328260, 321221, 425120, 427230, b) 327150, 326260, 320270, 321301, 422020
- Postal code
- 33004-2774
- Report date
- Jul 10, 2024
- Product type
- Drugs
- Recall number
- D-0574-2024
- Classification
- Class II
- Recalling firm
- Little Moon Essentials LLC
- Product quantity
- 1264 glass jars
- Reason for recall
- CGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA and Ontario, Canada (2 retailers)
- Recall initiation date
- Jun 20, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2024