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Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Class IIILow

FDAOct 24, 2012Nationwide• GlaxoSmithKline, LLC.

DayWear Sheer Tint (Estee Lauder) – Sunscreen Stability Concern (2012)

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.

Class IIILow

FDAOct 23, 2012Nationwide• Estee Lauder Inc

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Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)

DayWear Sheer Tint (Estee Lauder) – Sunscreen Stability Concern (2012)

Tapioca Stick (Asian Boy) – Undeclared Sulfites (2012)

Organic Fennel Seed (Swanson) – Product Defect (2012)

Acne Pore Cleanser (Valeant) – Subpotent Ingredient (2012)

Terminator Acne Treatment (Valeant) – Subpotent Ingredient (2012)

Acne Clearing System (Valeant) – Subpotent Ingredient (2012)

AcneFree 24 Hour Clearing System (Valeant) – Subpotent Active Ingredient (2012)

AcneFree Oil-Free Acne Cleanser (Valeant) – Subpotent Benzoyl Peroxide (2012)

Acne Astringent Pads (Valeant) – Subpotent Ingredient (2012)

AcneFree Acne Pore Cleanser (Valeant) – Subpotent Benzoyl Peroxide (2012)

AcneFree 3-in-1 Acne Night Repair Foam (Valeant) – Subpotent Ingredients (2012)

Yum Yummy Milk Vanilla Baby Cookies (Ella's Kitchen) - mold risk (2012)

Yum Yummy Apple Ginger Baby Cookies (Ella's Kitchen) - mold risk (2012)

Extra Fine Sugar (Alymaq) – Plastic Fragments (2012)

Lemon Hand Sanitizing Wipes (ITW Dymon) – Raw Material Issue (2012)

CellCept Capsules (Genentech) – Short Fill Packaging (2012)

Children's Cetirizine HCl Tablets (Sandoz) – Impurity Specification (2012)

Pramipexole Tablets 0.125mg (Sandoz) – Impurity Concern (2012)

Pramipexole Tablets 0.25mg (Sandoz) – Impurity Concern (2012)