Drug recall D-151-2013

Class III Terminated reported Feb 13, 2013

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

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.

Lots and codes

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

Recall details

Recalling firm
Estee Lauder Inc, New York, NY
Quantity
1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs
Distribution
Nationwide, Puerto Rico, Bermuda and Panama
Type
Voluntary: Firm initiated
Recall initiated
October 23, 2012
Terminated
April 3, 2017