Sensodyne Complete Protection Paste
FDA Recall NDC 0135-0572
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sensodyne Complete Protection (NDC 0135-0572). A significant event, classified as Class II, was initiated on Jul 15, 2015 by Haleon Us Holdings Llc. The reported reason for this action was: "Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Jul 15, 2015
Aug 19, 2015
50,860 tubes
Recall Profile & Regulatory Data
Event ID
71750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithkline Consmer Healthcare
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico & Taiwan
Termination Date
Apr 19, 2017
Product Description
SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 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 0135-0572-02
Batch or Lot Expiration Information
Lot# C4D061, Exp 03/16 C4E161, C4E211, Exp 04/16 C4F051, Exp 05/16 C4H111, Exp 07/16
Affected Packages Involved in this Recall
0135-0573-02Product
0135-0573-03Product
0135-0572-02Product
0135-0572-03Product
Class II Terminated
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Jul 15, 2015
Aug 19, 2015
81,376 tubes
Recall Profile & Regulatory Data
Event ID
71750
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GlaxoSmithkline Consmer Healthcare
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico & Taiwan
Termination Date
Apr 19, 2017
Product Description
SENSODYNE COMPLETE PROTECTION, 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 0135-0573-02
Batch or Lot Expiration Information
Lot# B4D031, Exp 03/16 B4E101, Exp 04/16 B4F261,B4F291,B4G011, Exp 05/16 B4G031, B4G091, Exp 06/16 B4J031, Exp 07/16
Affected Packages Involved in this Recall
0135-0573-02Product
0135-0573-03Product
0135-0572-02Product
0135-0572-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
