Drug product
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
D-1509-2020
Product summary
- Event
- Event 85903
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12,500 applicators
- Official record key
drug-enforcement:D-1509-2020
Official wording
Reason: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Code information: Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023
Distribution pattern: 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,
Derived failure modes
-
Unknown
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides