FDA (Drugs) recall action 86998
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
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.
Microbial Contamination of Non-Sterile Product: 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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CareFusion 213, LLC is recalling 400 cartons of Chloraprep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches.
CareFusion 213, LLC is recalling non-sterile ChloraPrep With Tint solution distributed in Puerto Rico and Oman due to potential fungal contamination.
CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches in hot, humid climates.
CareFusion 213, LLC is recalling Chloraprep One-Step applicators distributed in Puerto Rico and Oman due to potential fungal growth in hot, humid conditions.