CareFusion 213, LLC
CareFusion 213, LLC lists 3 drug products in the FDA National Drug Code directory.
Products
| NDC | Product | Strength | Type |
|---|---|---|---|
| 54365-400 | ChloraPrep One-Step Solution | Chlorhexidine Gluconate 20 mg/mL; Isopropyl Alcohol .7 mL/mL | OTC |
| 54365-401 | ChloraPrep Swabstick Solution | Chlorhexidine Gluconate 20 mg/mL; Isopropyl Alcohol .7 mL/mL | OTC |
| 54365-014 | PurPrep Sponge | Isopropyl Alcohol 725 mg/mL; Povidone-iodine 8.3 mg/mL | OTC |
Recalls by CareFusion 213, LLC
- D-0690-2026 Jul 22, 2026 · Class II
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator - D-0652-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0651-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0650-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0649-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0648-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0647-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0646-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0645-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0644-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0643-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0625-2026 Jul 1, 2026 · Class I
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - D-0624-2026 Jul 1, 2026 · Class I
Non-Sterility: Due to presence of Aspergillus penicillioides. - D-0623-2026 Jul 1, 2026 · Class II
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - D-0622-2026 Jul 1, 2026 · Class II
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - D-0518-2026 May 13, 2026 · Class II
Lack of assurance of Sterility: potential product contamination - D-0517-2026 May 13, 2026 · Class II
Lack of assurance of Sterility: potential product contamination - D-0243-2026 Jan 7, 2026 · Class II
Lack of Assurance of Sterlity - D-0441-2025 May 28, 2025 · Class II
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. - D-0259-2025 Mar 19, 2025 · Class I
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.