Drug product
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
D-0652-2026
Product summary
- Event
- Event 99217
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 units
- Official record key
drug-enforcement:D-0652-2026
Official wording
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Code information: Lot: 4190081, Exp 06/30/2027
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility