Drug 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.
D-0625-2026
Product summary
- Event
- Event 99114
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 178,000 applicators
- Official record key
drug-enforcement:D-0625-2026
Official wording
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.
Code information: Lot # 4073005, Exp 03/31/2027
Distribution pattern: Nationwide inthe USA, as well as other foreign distribution.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility