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.
Sensodyne Extra Fresh Repair & Protect (Stannous 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
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02
Affected NDC
0135-0547-02
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| SENSODYNE Repair and Protect Extra Fresh stannous fluoride NDC 00135-0547 |
1.1 mg/g | Paste Oral |
Haleon US Holdings LLC | OTC |
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
- NDC code
- 0135-0547-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1323-2015 · 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 recalls by GlaxoSmithkline Consmer Healthcare
All 2015 recalls
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.
Class II · Moderate risk
biotene PBF Toothpaste
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Other particulate / foreign matter recalls from 2015
All particulate / foreign matter recalls
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class II · Moderate risk
Baclofen USP powder
Presence of Foreign Substance
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