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.
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.
Official details
- Category
- Drug recall
- Status
- Ongoing
- Classification
- Class I
- Company or vendor
- CareFusion 213, LLC
- Affected product
- Nationwide inthe USA, as well as other foreign distribution.
- Risk or reason
- 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.
- Remedy or action
- Lot # 4073005, Exp 03/31/2027
- Official ID
- D-0625-2026