BD ChloraPrep Clear Applicators recalled over sterility concerns

Recall date

February 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CareFusion 213, LLC recalls BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient…

Recall number

D-0259-2025

FDA classification

Class I

Brand / firm

CareFusion 213, LLC

Sold / distributed

Nationwide and Canada

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.