June 2014 FDA Recall Drug by Estee Lauder Inc
D-1452-2014 - Stability Data Does Not Support Expiry

This Class III drug recall was voluntarily initiated by Estee Lauder Inc on June 6, 2014 for the product Drug. The FDA reported the reason for recall as stability data does not support expiry. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1452-2014

Reason for Recall
Stability Data Does Not Support Expiry
Initiated
06-06-2014
Reported
07-30-2014
Quantity
3,791 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68449
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.
Estee Lauder Inc
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-19-2015
Product Description About Product Description
Full technical description of the product.
DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France

Batch or Lot Expiration Information

Lot# All lot codes and shipment dates are being recalled. 2.6oz/75ml. in a light green carton, UPC: 8-82381-07901-7 Code: D079-01-1000