D-1509-2020 Class I Terminated
FDA drug recall D-1509-2020 was initiated by CareFusion 213, LLC on June 23, 2020 and is designated Class I. Reason for recall: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides The recall status is terminated (terminated September 28, 2022). Affected quantity: 12,500 applicators.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2020
- Initiation Date
- June 23, 2020
- Termination Date
- September 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,500 applicators
Product Description
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
Reason for Recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
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,
Code Information
Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023