FDA recall D-1510-2020

Product

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

Reason for recall

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

Distribution

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,

Key facts

Status

Terminated

Initiation date

2020-06-23

Report date

2020-08-26

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Paso, TX, United States

Primary source

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