BD ChloraPrep Clear recalled over sterility concerns

Recall date

May 15, 2025

Source

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

Official notice title

CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Ski…

Recall number

D-0441-2025

FDA classification

Class II

Brand / firm

CareFusion 213, LLC

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.