Multi event Drug Recall Enforcement Report Class I voluntary initiated by CareFusion 213, LLC, originally initiated on 06-23-2020 for the 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 The product was recalled due to non-sterility: product is being recalled due to presence of aspergillus penicilloides. The product was distributed in 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, and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1510-2020 | 06-23-2020 | 08-26-2020 | Class I | 2,800,800 applicators | 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 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Terminated |
| D-1509-2020 | 06-23-2020 | 08-26-2020 | Class I | 12,500 applicators | BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Terminated |
| D-1511-2020 | 06-23-2020 | 08-26-2020 | Class I | 4,272,300 applicators | ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Terminated |
Recalled Products
