CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution,
Recalled May 5, 2021 · FDA recall D-0344-2021 · CareFusion 213
Hazard
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. · FDA Class I
Units
1,434,000 cartons
Sold at
Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Description
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Product
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Manufacturer(s)
CareFusion 213, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →