FDA Drug recall D-1323-2015
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmit…
- FDA Drug
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmit… by Glaxosmithkline Consmer Healthcare, citing presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1323-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-15 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glaxosmithkline Consmer Healthcare |
| Distribution | US |
Product
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
Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Identifiers
| ndc | 0135-0548-02 |
|---|---|
| ndc | 0135-0548-01 |
| ndc | 0135-0547-02 |
| ndc | 0135-0575-01 |
| code_info | Lot # Q3H061, Q3H081, Q3H101, Q3H131, Exp 07/15 Q3J101, Q3J121, Q3J261, Q3J291, Exp 08/15 Q3K161, Q3K181, Q3K211,…Lot # Q3H061, Q3H081, Q3H101, Q3H131, Exp 07/15 Q3J101, Q3J121, Q3J261, Q3J291, Exp 08/15 Q3K161, Q3K181, Q3K211, Q3M021, Exp 09/15 Q3M071, QEM251, Exp 10/15 Q3N021, Q3N211, Exp 11/15 Q4A071, Q4A111, Q4A251, Q4B201, Exp 12/15 Q4C151, Q4C191, Exp 12/16 Q4D111, Q4D151, Q4D151R, Exp 03/16 Q4E151, Q4E151R, Q3E152, Exp 04/16 Q4F161, Q4F201, Exp 05/16 Q4G271, Q4G301, Exp 06/16 Q4J051, Exp 08/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1323-2015%22
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