February 2017 FDA Recall Prevident by Colgate Palmolive Co
D-0521-2017 - Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.

This Class III drug recall was voluntarily initiated by Colgate Palmolive Co on February 13, 2017 for the product Prevident. The FDA reported the reason for recall as label mix up; rear panel is incorrectly labeled with the prevident 5000 enamel protect rear panel.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0521-2017

Reason for Recall
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Initiated
02-13-2017
Reported
03-22-2017
Quantity
14,656 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76516
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Colgate Palmolive Co
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-13-2017
Product Description About Product Description
Full technical description of the product.
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

0126-0016-61 Prevident 5000 Dry Mouth