Class III · Low risk
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15
Defective container: Ineffective seal between the cap and jar of the affected product.
ESTEE LAUDER DayWear Sheer Tint Release
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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
Affected NDC
11559-0008-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Estee Lauder Inc
- NDC code
- 11559-008-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-151-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Estee Lauder Inc
All 2012 recalls
Class III · Low risk
DENBLAN Anticavity Fluoride Toothpaste
Stability Data Does Not Support Expiry
Other stability / shelf life recalls from 2012
All stability / shelf life recalls
Class II · Moderate risk
Fluorouracil Topical Cream USP
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
Major Oral Peroxide
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
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