BD ChloraPrep Hi-Lite Orange recall (CareFusion 213, LLC)
DrugClass IIOngoing
Summary: CareFusion 213, LLC is recalling BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, C. Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel.
What is being recalled
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Why
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Distributed Nationwide in the USA
How to tell if yours is affected
Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0643-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 11, 2026 |
| Reported | July 8, 2026 |
| Company | CareFusion 213, LLC |
| Company location | El Paso, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,800 units |
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