FDAFDA · Food and drugs·Recall number D-0441-2025
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.
Published May 28, 2025 · Recall initiated: May 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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