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- Recall Enforcement Event ID: 71750
Recall Enforment Report D-1321-2015
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by GlaxoSmithkline Consmer Healthcare, originally initiated on 07-15-2015 for the product 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 The product was recalled due to presence of foreign substance: fragments of wood found when the product was extruded onto a toothbrush.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1321-2015 | 07-15-2015 | 08-19-2015 | Class II | 50,860 tubes | 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 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
| D-1317-2015 | 07-15-2015 | 08-19-2015 | Class II | 30,516 tubes | biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
| D-1320-2015 | 07-15-2015 | 08-19-2015 | Class II | 50,860 tubes | biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
| D-1324-2015 | 07-15-2015 | 08-19-2015 | Class II | 325,504 tubes | SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
| D-1318-2015 | 07-15-2015 | 08-19-2015 | Class II | 366,192 tubes | 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 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
| D-1319-2015 | 07-15-2015 | 08-19-2015 | Class II | 111,892 tubes | biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
| D-1322-2015 | 07-15-2015 | 08-19-2015 | Class II | 81,376 tubes | 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 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
| D-1323-2015 | 07-15-2015 | 08-19-2015 | Class II | 335,676 tubes | 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 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | Terminated |
Recalled Products
| NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
|---|---|---|---|---|---|---|
| 0135-0547 | Sensodyne Repair and Protect Extra Fresh | Stannous Fluoride | Paste | Oral | Haleon Us Holdings Llc | Human Otc Drug |
| 0135-0548 | Sensodyne Repair and Protect | Stannous Fluoride | Paste | Oral | Haleon Us Holdings Llc | Human Otc Drug |
| 0135-0557 | Biotene Fresh Mint Original | Sodium Fluoride | Paste | Oral | Haleon Us Holdings Llc | Human Otc Drug |
| 0135-0558 | Biotene Gentle Mint | Sodium Fluoride | Paste | Oral | Haleon Us Holdings Llc | Human Otc Drug |
| 0135-0572 | Sensodyne Complete Protection Extra Fresh | Stannous Fluoride | Paste | Dental | Haleon Us Holdings Llc | Human Otc Drug |
| 0135-0573 | Sensodyne Complete Protection | Stannous Fluoride | Paste | Dental | Haleon Us Holdings Llc | Human Otc Drug |
| 0135-0575 | Sensodyne Repair and Protect Whitening | Stannous Fluoride | Paste | Oral | Haleon Us Holdings Llc | Human Otc Drug |
Recall Enforcement Report D-1321-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1321-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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
- Reason For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 50,860 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- Lot # C4D061, Exp 03/16 C4E161, C4E211, Exp 04/16 C4F051, Exp 05/16 C4H111, Exp 07/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0135-0573-02; 0135-0573-03; 0135-0572-02; 0135-0572-03
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1317-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1317-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
- Reason For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 30,516 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- Lot # Y2J101, Y2J111, Exp 08/15 Y3D031, Exp 02/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1320-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1320-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
- Reason For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 50,860 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- Lot # a) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1324-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1324-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
- Reason For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 325,504 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- Lot # a) R3J181, Exp 08/15 R4A191, R4A192, R41291, R4B011, Exp 12/15 R4C111, Exp 02/16 Lot # b) R3G291, R3H011, Exp 06/15 R3H191, R3H261, R3H291, Exp 07/15 R3J171, R3J182, R3J191, R3J241, Exp 08/15 R3K031, R3K121, R3K221, R3K291, Exp 09/15 R3M111, R3M181, Exp 10/15 R3N081, R3N101, Exp 11/15 R4A211, Exp 12/15 R4B281, Exp 01/16 R4C041, R4C291, R4D021, Exp 02/16 R4D081, Exp 03/16 R4E231, Exp 04/16 R4F081, Exp 05/16 R4G191, Exp 06/16 R4H031, R4H071, R4H271, Exp 07/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1318-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1318-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 366,192 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- Lot # a) X3G121, X3H141, Exp 06/16 X3K121, Exp 09/16 X4D281, Exp 03/17 X4G181, Exp 06/17 b) X3C041, Exp 01/16 c) X3F032, Exp 04/16 X3G101, X3G131, Exp 06/16 X3H171, X3H211, X3H291, Exp 07/16 X3J271, Exp 08/16 X3K021, X3K171, X3K291, Exp 09/16 X3M121, Exp 10/16 X3N171, Exp 11/16 X4B061, X4B081, Exp 01/17 X4C121, X4C251, Exp 02/17 X4D291, X4D301, Exp 03/17 X4E081, X4G131, Exp 04/17 X4H111, Exp 06/17 d) X2H021, Exp 07/15 X2K151, X2K231 Exp 09/15 X3B211,X3C012, X3C011, Exp 01/16 X3C141, X3C251, Exp 02/16 X3G021, Exp 06/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0135-0557-01; 0135-0557-02; 0135-0558-01; 0135-0487-02; 0135-0487-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1319-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1319-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
- Reason For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 111,892 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- Lot # Y3E211, Exp 04/16 Y3G231, Y3G251, Exp 06/16 Y3J231,Y3N191 Exp 08/16 Y3N171, Exp 11/16 Y4A141, Exp 12/16 Y4C271, Exp 02/17 Y4E131, Exp 04/17 Y4G101, Exp 05/17 Y4H191, Exp 06/17 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0135-0557-01; 0135-0557-02; 0135-0558-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1322-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1322-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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
- Reason For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 81,376 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- Lot # B4D031, Exp 03/16 B4E101, Exp 04/16 B4F261,B4F291,B4G011, Exp 05/16 B4G031, B4G091, Exp 06/16 B4J031, Exp 07/16 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0135-0573-02; 0135-0573-03; 0135-0572-02; 0135-0572-03
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-1323-2015
- Event ID
- 71750 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1323-2015 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide, Puerto Rico & Taiwan What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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 For Recall
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 335,676 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 08-19-2015
- Recall Initiation Date
- 07-15-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- GlaxoSmithkline Consmer Healthcare
- Code Info
- 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
