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

BD ChloraPrep FREPP Clear Recall Summary BD ChloraPrep FREPP Clear (a skin antiseptic solution in 1.5 mL applicators) is being recalled because some packages may not be sterile due to a fungus contamination and wrinkles in the packaging seal that could allow contamination. The affected product was distributed nationwide across all U.S. states and some foreign countries.

Recalling firm
CareFusion 213, LLC
Product
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Reason
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.
Classification
Class I
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-05-28
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide inthe USA, as well as other foreign distribution.

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

Recall details on Nibble Recalls: https://trynibble.app/recalls/0523759c-a8c8-4c09-9ce7-c9c6959cfb76