FDA recall D-0625-2026

CareFusion 213, LLC · Class I · drug

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 for recall

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.

Distribution

Nationwide inthe USA, as well as other foreign distribution.

Key facts

Status
Ongoing
Initiation date
2026-05-28
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0625-2026