Class III · Low risk
Sensodyne PRONAMEL
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Orajel Kids My Way! Anticavity Fluoride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
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
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.
Drug: Fluoride
- Recalling firm
- Church & Dwight Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-061-2013 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluoride recalls
See all
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Other recalls by Church & Dwight Inc
All 2012 recalls
Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Class II · Moderate risk
Zicam" Medicated Fruit Drops Elderberry Flavor
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class I · High risk
Orajel Baby
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I · High risk
Zicam Nasal Allclear
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
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