D-151-2013 Class III Terminated
FDA drug recall D-151-2013 was initiated by Estee Lauder Inc on October 23, 2012 and is designated Class III. 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. The recall status is terminated (terminated April 3, 2017). Affected quantity: 1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs.
Recall Details
- Product Type
- Drugs
- Report Date
- February 13, 2013
- Initiation Date
- October 23, 2012
- Termination Date
- April 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs
Product Description
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.
Distribution Pattern
Nationwide, Puerto Rico, Bermuda and Panama
Code Information
A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41.