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
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original (Sodium Fluoride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Affected NDCs
0135-0487-01
0135-0487-02
0135-0557-01
0135-0557-02
Compare with the code on your package — it is the most precise check available.
Drug: Fluoride
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| BIOTENE Fresh Mint Original sodium fluoride NDC 00135-0557 |
1.5 mg/g | Paste Oral |
Haleon US Holdings LLC | OTC |
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
- NDC code
- 0135-0557-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1318-2015 · 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
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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 GlaxoSmithkline Consmer Healthcare
All 2015 recalls
Class II · Moderate risk
Sensodyne With Fluoride Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Extra Fresh Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Extra Fresh Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
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