FDA Recall D-0573-2024
Little Moon Essentials LLC · Dania Beach, FL
Class II Ongoing 693 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
CGMP deviations
Recall record
- Recall number
D-0573-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA and Ontario, Canada (2 retailers)
- Recall initiated
- 2024-06-20
- Classified by FDA Center
- 2024-07-02
- FDA published
- 2024-07-10
- Recalling firm
- Little Moon Essentials LLC
- Firm location
- Dania Beach, FL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.