Drug product
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
D-0649-2026
Product summary
- Event
- Event 99217
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,200 units
- Official record key
drug-enforcement:D-0649-2026
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: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility