FDAHealthMay 28, 2026
CareFusion 213, LLC — BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El
⚠️ Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 28, 2026
Nationwide inthe USA, as well as other foreign distribution.
What's affected?
- Product
- BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
- Brand
- CHLORAPREP ONE-STEP
- Lot code
- 4073005
Additional details
Lot # 4073005, Exp 03/31/2027
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 178,000 applicators.
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