October 2012 FDA Recall Drug by Estee Lauder Inc
D-151-2013 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Estee Lauder Inc on October 23, 2012 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-151-2013

Reason for Recall
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Initiated
10-23-2012
Reported
02-13-2013
Quantity
1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63510
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico, Bermuda and Panama
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2017
Product Description About Product Description
Full technical description of the product.
ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01

Batch or Lot Expiration Information

Lot# A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41.