Recalls / Class II
Class IID-1168-2023
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).
- Brand name
- Chloraprep One-step
- Generic name
- Chlorhexidine Gluconate And Isopropyl Alcohol
- Active ingredients
- Chlorhexidine Gluconate, Isopropyl Alcohol
- Route
- Topical
- NDC
- 54365-400
- FDA application
- NDA020832
- Affected lot / code info
- Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025
Why it was recalled
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.
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, El Paso, Texas 79912-8000
Distribution
- Quantity
- 398,160 cartons
- Distribution pattern
- Distributed nationwide to 100 consignees. Please refer to consignee list.
Timeline
- Recall initiated
- 2023-08-25
- FDA classified
- 2023-09-15
- Posted by FDA
- 2023-09-27
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1168-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.