Carefusion 213, Llc: Chloraprep Frepp, Clear, (2% W/v Chlorhexidine Gluconate (chg) And 70% V/v Isopropyl Alcohol) 500 X 1

ChloraPrep FREPP Recall Summary CareFusion is recalling ChloraPrep FREPP skin antiseptic applicators (500 x 1.5 mL packages, NDC 54365-400-30) distributed nationwide because they were not properly sterilized before being sold to customers. The products were meant to be sent for sterilization but were distributed through the wrong channel instead. This recall is classified as Class II and affects all U.S. states and Washington D.C.

Recalling firm

CareFusion 213, LLC

Product

ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB

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

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-11

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Distributed Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/8aecdefa-33d7-4921-9aea-a9ae25a61aa1