FDA recall D-0259-2025

CareFusion 213, LLC · Class I · drug

Product

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

Reason for recall

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Distribution

Nationwide and Canada

Key facts

Status
Ongoing
Initiation date
2025-02-14
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0259-2025