Drug product
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
D-0441-2025
Product summary
- Event
- Event 96879
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 385,200 applicators
- Official record key
drug-enforcement:D-0441-2025
Official wording
Reason: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Code information: Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Labeling or packaging
open seal
-
Sterility assurance
Lack of Assurance of Sterility