Class II · Moderate risk
DermaSarra
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Little Moon Essentials
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDCs
70722-0260-02
70722-0260-04
Compare with the code on your package — it is the most precise check available.
Drug: Camphor
- Recalling firm
- Little Moon Essentials LLC
- NDC code
- 70722-260-04
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0572-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Camphor recalls
See all
Class I · High risk
DermaSarra
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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cGMP Deviations
Other recalls by Little Moon Essentials LLC
All 2024 recalls
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
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