Recalls / Class I
Class ID-0259-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- 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 #: 3200240, Exp 6/30/2026
Why it was recalled
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, El Paso, Texas 79912-8000
Distribution
- Quantity
- 205,440 applicators
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2025-02-14
- FDA classified
- 2025-03-07
- Posted by FDA
- 2025-03-19
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0259-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.