Biotene Paste
FDA Recall NDC 0135-0557
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 Biotene (NDC 0135-0557). 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
366,192 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
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
0135-0557-01Product
0135-0557-02Product
0135-0558-01Product
0135-0487-02Product
0135-0487-01Product
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
111,892 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
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
0135-0557-01Product
0135-0557-02Product
0135-0558-01Product
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.
