FDA-Drug2021-05-05Class II
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Hazard
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Sold states
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.
Affected count
7,990,100 cartons
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2021More CareFusion 213, LLC recalls
- FDA-Drug2026-07-01BD ChloraPrep Clear skin antiseptic recalled for sterility assurance due to packaging defect
- FDA-Drug2026-07-01BD ChloraPrep FREPP Clear skin antiseptic recalled for potential sterility breach
- FDA-Drug2026-07-01BD ChloraPrep Clear antiseptic solution recalled for non-sterility due to fungal contamination
- FDA-Drug2026-07-01BD ChloraPrep FREPP Clear skin antiseptic recalled for non-sterility and potential contamination
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