Prevident Gel, Dentifrice
FDA Recall NDC 0126-0016
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 Prevident (NDC 0126-0016). A significant event, classified as Class III, was initiated on Feb 13, 2017 by Colgate Oral Pharmaceuticals, Inc.. The reported reason for this action was: "Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel."
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
February 2017 Class III Recall: Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Recall Number
Class III Terminated
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Feb 13, 2017
Mar 22, 2017
14,656 bottles
Recall Profile & Regulatory Data
Event ID
76516
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Colgate Palmolive Co
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 13, 2017
Product Description
PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622
Batch or Lot Expiration Information
Lot# Lots: 6350US561G, 6350US562G, 6351US561G, 6351US562G
Affected Packages Involved in this Recall
0126-0016-61Product
3834110622Product
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.
