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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CareFusion 213, LLC
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
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).
Product Codes/Lot Numbers:
Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1168-2023
Related Recalls
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.