Recalls / Class II
Class IID-0441-2025
Product
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.
- Brand name
- Chloraprep One-step
- Generic name
- Chlorhexidine Gluconate And Isopropyl Alcohol
- Active ingredients
- Chlorhexidine Gluconate, Isopropyl Alcohol
- Route
- Topical
- NDC
- 54365-400
- FDA application
- NDA020832
- Affected lot / code info
- Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Why it was recalled
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000
Distribution
- Quantity
- 385,200 applicators
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2025-05-15
- FDA classified
- 2025-05-20
- Posted by FDA
- 2025-05-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0441-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.