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ChloraPrep With Tint (CareFusion) – Product Contamination (2020)

Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Class IHigh

FDAJul 7, 2020IN, PR• CareFusion 213, LLC

BD ChloraPrep Hi-Lite Orange (CareFusion) – Non-Sterility Risk (2020)

Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Class IHigh

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ChloraPrep With Tint (CareFusion) – Product Contamination (2020)

BD ChloraPrep Hi-Lite Orange (CareFusion) – Non-Sterility Risk (2020)

BD ChloraPrep Clear (CareFusion) – Non-Sterility Risk (2020)

Skin Medica Acne System (Allergan) – Potency Failure (2020)

Progesterone 150 mg Troche (MasterPharm) – Processing Controls Issue (2020)

Calcium Citrate Powder (MasterPharm) – Processing Controls Issue (2020)

Vancomycin HCL 1.5 mg (Edge Pharma) – Labeling Strength Error (2020)

Cub Scout Activity Pins (Boy Scouts) – Lead Content (2020)

Bay Leaves Herbs (Sundial) – Misbranded Drugs (2020)

Broom Weed Herbs (Sundial) – Misbranded Drugs (2020)

Quassia Wood Herbs (Sundial) – Misbranded Drugs (2020)

Mojo Bush Herbs (Sundial) – Misbranded Drugs (2020)

Spanish Needles Herbs (Sundial) – Misbranded Drugs (2020)

Organic Herbs Sarsaparilla (Sundial) – Misbranded (2020)

Black Sage Herbs (Sundial) - Misbranded Drugs (2020)

Cassava Meal (Sundial) – Misbranded (2020)

Mitmitta Cayenne Pepper (Sundial) – Misbranded (2020)

Princess Almaz Spiced Tea (Sundial) – Misbranded (2020)

Mango Bark Herbs (Sundial) - Misbranded Drugs (2020)

Mahogany Bark Herbal Product (Sundial) – Misbranded Herbs (2020)