FDA-Drug2020-08-26Class I

ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11

CareFusion 213, LLC
Hazard

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

Sold states
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Affected count
2,800,800 applicators
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)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1510-2020

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