Class II
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.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
- Recall number
- D-0441-2025
- Report date
- May 28, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- CareFusion 213, LLC
- Generic names
- CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
- Brand names
- CHLORAPREP ONE-STEP
- Product NDCs
- 54365-400
Code and lot information
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Distribution
Nationwide in the U.S.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.