Drug 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.
D-0259-2025
Product summary
- Event
- Event 96262
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 205,440 applicators
- Official record key
drug-enforcement:D-0259-2025
Official wording
Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Code information: Lot #: 3200240, Exp 6/30/2026
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Unknown
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.