BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL A… recall
CareFusion 213, LLC recalled BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL A… on July 1, 2026 because of non-Sterility: Due to presence of Aspergillus penicillioides. It was sold nationwide.
Why it was recalled
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.
What's recalled
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.
Quantity: 178,000 applicators
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- CareFusion 213, LLC, El Paso, TX
- Date
- Severity
- Class I · most serious
the most serious: the product could cause serious health problems or death. - Where sold
- Nationwide
Nationwide inthe USA, as well as other foreign distribution. - Status
- Ongoing
- Recall number
- D-0625-2026
- Source
- U.S. Food and Drug Administration
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