Drug product
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).
D-1168-2023
Product summary
- Event
- Event 92917
- Status
- Completed
- Classification
- Class II
- Quantity
- 398,160 cartons
- Official record key
drug-enforcement:D-1168-2023
Official wording
Reason: Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
Code information: Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025
Distribution pattern: Distributed nationwide to 100 consignees. Please refer to consignee list.
Derived failure modes
-
Potency or specification failure
Stability data does not support expiry