Parodontax Paste
FDA Recall NDC 0135-0601
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Parodontax (NDC 0135-0601). A significant event, classified as Class II, was initiated on Jun 28, 2017 by Haleon Us Holdings Llc. The reported reason for this action was: "Presence of Foreign Substance: possibility of the presence of metal in the product."
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: possibility of the presence of metal in the product.
Jun 28, 2017
Jul 12, 2017
15,708 tubes
Recall Profile & Regulatory Data
Event ID
77651
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GSK Consumer Healthcare
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Feb 07, 2020
Product Description
parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.
Batch or Lot Expiration Information
Lot# G7E101, Exp 04/19
Affected Packages Involved in this Recall
0135-0598-01Product
0135-0598-02Product
0135-0599-01Product
0135-0599-02Product
0135-0601-01Product
0135-0601-02Product
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.
